Generic INOmax Availability
Last updated on Apr 10, 2025.
INOmax is a brand name of nitric oxide, approved by the FDA in the following formulation(s):
INOMAX (nitric oxide - gas;inhalation)
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Manufacturer: MALLINCKRODT HOSP
Approval date: December 23, 1999
Strength(s): 100PPM (discontinued) [RLD], 800PPM [RLD] [AA] -
Manufacturer: MALLINCKRODT HOSP
Approval date: January 17, 2023
Strength(s): 4880PPM [RLD]
Is there a generic version of INOmax available?
A generic version of INOmax has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to INOmax and have been approved by the FDA:
NOXIVENT (nitric oxide gas;inhalation)
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Manufacturer: LINDE GAS EQUIP
Approval date: October 2, 2018
Strength(s): 800PPM [AA]
ULSPIRA (nitric oxide gas;inhalation)
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Manufacturer: AIRGAS THERAP
Approval date: July 27, 2023
Strength(s): 800PPM [AA]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of INOmax. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Methods of administering inhaled nitric oxide gas
Patent 11,931,377
Issued: March 19, 2024
Inventor(s): Baldassarre; James S.
Assignee(s): Mallinckrodt Hospital Products IP Limited (N/A, IE)The invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.
Patent expiration dates:
- June 3, 2029✓✓✓
- June 3, 2029
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Methods of administering inhaled nitric oxide gas
Patent 11931377*PE
Issued: March 19, 2024
Inventor(s): Baldassarre; James S.
Assignee(s): Mallinckrodt Hospital Products IP Limited (N/A, IE)The invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.
Patent expiration dates:
- December 3, 2029
- December 3, 2029
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Methods of reducing the risk of occurrence of pulmonary edema in children in need of treatment with inhaled nitric oxide
Patent 8,282,966
Issued: October 9, 2012
Inventor(s): Baldassarre James S. & Rosskamp Ralf
Assignee(s): INO Therapeutics LLCThe invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.
Patent expiration dates:
- June 30, 2029✓
- June 30, 2029
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Methods of reducing the risk of occurrence of pulmonary edema in children in need of treatment with inhaled nitric oxide
Patent 8282966*PED
Issued: October 9, 2012
Inventor(s): Baldassarre James S. & Rosskamp Ralf
Assignee(s): INO Therapeutics LLCThe invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.
Patent expiration dates:
- December 30, 2029✓
- December 30, 2029
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Gas delivery device and system
Patent 8,291,904
Issued: October 23, 2012
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): INO Therapeutics LLCA gas delivery system including a gas delivery device, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gas are also described.
Patent expiration dates:
- January 6, 2031✓✓
- January 6, 2031
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Gas delivery device and system
Patent 8291904*PED
Issued: October 23, 2012
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): INO Therapeutics LLCA gas delivery system including a gas delivery device, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gas are also described.
Patent expiration dates:
- July 6, 2031✓
- July 6, 2031
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Methods of reducing the risk of occurrence of pulmonary edema in term or near-term neonates in need of treatment with inhaled nitric oxide
Patent 8,293,284
Issued: October 23, 2012
Inventor(s): Baldassarre James S. & Rosskamp Ralf
Assignee(s): INO Therapeutics LLCThe invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.
Patent expiration dates:
- June 30, 2029✓
- June 30, 2029
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Methods of reducing the risk of occurrence of pulmonary edema in term or near-term neonates in need of treatment with inhaled nitric oxide
Patent 8293284*PED
Issued: October 23, 2012
Inventor(s): Baldassarre James S. & Rosskamp Ralf
Assignee(s): INO Therapeutics LLCThe invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.
Patent expiration dates:
- December 30, 2029✓
- December 30, 2029
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Methods of reducing the risk of occurrence of pulmonary edema associated with inhalation of nitric oxide gas
Patent 8,431,163
Issued: April 30, 2013
Inventor(s): Baldassarre James S. & Rosskamp Ralf
Assignee(s): INO Therapeutics LLCDisclosed are methods of reducing the risk of occurrence of pulmonary edema associated with a medical treatment comprising inhalation of nitric oxide gas.
Patent expiration dates:
- June 30, 2029✓
- June 30, 2029
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Methods of reducing the risk of occurrence of pulmonary edema associated with inhalation of nitric oxide gas
Patent 8431163*PED
Issued: April 30, 2013
Inventor(s): Baldassarre James S. & Rosskamp Ralf
Assignee(s): INO Therapeutics LLCDisclosed are methods of reducing the risk of occurrence of pulmonary edema associated with a medical treatment comprising inhalation of nitric oxide gas.
Patent expiration dates:
- December 30, 2029✓
- December 30, 2029
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Gas delivery device and system
Patent 8,573,209
Issued: November 5, 2013
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): INO Therapeutics LLCA gas delivery system including a gas delivery device (), a control module () and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve () assembly with a valve and circuit including a memory (), a processor () and a transceiver () in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator () and a breathing circuit (). Methods of administering gas are also described.
Patent expiration dates:
- January 6, 2031✓
- January 6, 2031
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Gas delivery device and system
Patent 8573209*PED
Issued: November 5, 2013
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): INO Therapeutics LLCA gas delivery system including a gas delivery device (), a control module () and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve () assembly with a valve and circuit including a memory (), a processor () and a transceiver () in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator () and a breathing circuit (). Methods of administering gas are also described.
Patent expiration dates:
- July 6, 2031✓
- July 6, 2031
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Nitric oxide delivery device
Patent 8,573,210
Issued: November 5, 2013
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): INO Therapeutics LLCA nitric oxide delivery device including a valve assembly, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gases containing nitric oxide are also described.
Patent expiration dates:
- January 6, 2031✓✓
- January 6, 2031
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Nitric oxide delivery device
Patent 8573210*PED
Issued: November 5, 2013
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): INO Therapeutics LLCA nitric oxide delivery device including a valve assembly, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gases containing nitric oxide are also described.
Patent expiration dates:
- July 6, 2031✓
- July 6, 2031
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Nitric oxide delivery device
Patent 8,776,794
Issued: July 15, 2014
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): INO Therapeutics LLCA nitric oxide delivery device including a valve assembly, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gases containing nitric oxide are also described.
Patent expiration dates:
- January 6, 2031✓✓
- January 6, 2031
-
Nitric oxide delivery device
Patent 8776794*PED
Issued: July 15, 2014
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): INO Therapeutics LLCA nitric oxide delivery device including a valve assembly, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gases containing nitric oxide are also described.
Patent expiration dates:
- July 6, 2031✓
- July 6, 2031
-
Gas delivery device and system
Patent 8,776,795
Issued: July 15, 2014
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): INO Therapeutics LLCA gas delivery system including a gas delivery device, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gas are also described.
Patent expiration dates:
- January 6, 2031✓✓
- January 6, 2031
-
Gas delivery device and system
Patent 8776795*PED
Issued: July 15, 2014
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): INO Therapeutics LLCA gas delivery system including a gas delivery device, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gas are also described.
Patent expiration dates:
- July 6, 2031✓
- July 6, 2031
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Methods for treating patients who are candidates for inhaled nitric oxide treatment
Patent 8,795,741
Issued: August 5, 2014
Inventor(s): Baldassarre James S.
Assignee(s): INO Therapeutics LLCDisclosed are methods of reducing the risk that a medical treatment comprising inhalation of nitric oxide gas will induce an increase in pulmonary capillary wedge pressure in the patient, leading to pulmonary edema.
Patent expiration dates:
- June 30, 2029✓
- June 30, 2029
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Methods for treating patients who are candidates for inhaled nitric oxide treatment
Patent 8795741*PED
Issued: August 5, 2014
Inventor(s): Baldassarre James S.
Assignee(s): INO Therapeutics LLCDisclosed are methods of reducing the risk that a medical treatment comprising inhalation of nitric oxide gas will induce an increase in pulmonary capillary wedge pressure in the patient, leading to pulmonary edema.
Patent expiration dates:
- December 30, 2029✓
- December 30, 2029
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Methods of distributing a pharmaceutical product comprising nitric oxide gas for inhalation
Patent 8,846,112
Issued: September 30, 2014
Inventor(s): Baldassarre James S.
Assignee(s): INO Therapeutics LLCDisclosed are methods of distributing a pharmaceutical product comprising nitric oxide gas. The methods include supplying a source of nitric oxide gas to a medical provider, informing the medical provider about a recommended dose of inhaled nitric oxide gas for treatment of neonates with hypoxic respiratory failure, and providing a warning about use of inhaled nitric oxide in patients with pre-existing left ventricular dysfunction.
Patent expiration dates:
- June 30, 2029✓
- June 30, 2029
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Methods of distributing a pharmaceutical product comprising nitric oxide gas for inhalation
Patent 8846112*PED
Issued: September 30, 2014
Inventor(s): Baldassarre James S.
Assignee(s): INO Therapeutics LLCDisclosed are methods of distributing a pharmaceutical product comprising nitric oxide gas. The methods include supplying a source of nitric oxide gas to a medical provider, informing the medical provider about a recommended dose of inhaled nitric oxide gas for treatment of neonates with hypoxic respiratory failure, and providing a warning about use of inhaled nitric oxide in patients with pre-existing left ventricular dysfunction.
Patent expiration dates:
- December 30, 2029✓
- December 30, 2029
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Gas delivery device and system
Patent 9,265,911
Issued: February 23, 2016
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): Mallinckrodt Hospital Products IP LimitedA gas delivery system including a gas delivery device, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gas are also described.
Patent expiration dates:
- January 6, 2031✓✓
- January 6, 2031
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Gas delivery device and system
Patent 9265911*PED
Issued: February 23, 2016
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): Mallinckrodt Hospital Products IP LimitedA gas delivery system including a gas delivery device, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gas are also described.
Patent expiration dates:
- July 6, 2031✓
- July 6, 2031
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Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide
Patent 9,279,794
Issued: March 8, 2016
Inventor(s): Tolmie Craig R. & Milsap Jeff & Acker Jaron M.
Assignee(s): Mallinckrodt Hospital Products IP LimitedDescribed are systems and methods for compensating long term sensitivity drift of catalytic type electrochemical gas sensors used in systems for delivering therapeutic nitric oxide (NO) gas to a patient by compensating for drift that may be specific to the sensors atypical use in systems for delivering therapeutic nitric oxide gas to a patient. In at least some instances, the long term sensitivity drift of catalytic type electrochemical gas sensors can be addressed using calibration schedules, which can factor in the absolute change in set dose of NO being delivered to the patient that can drive one or more baseline calibrations. The calibration schedules can be used reduce the amount of times the sensor goes offline. Systems and methods described may factor in in actions occurring at the delivery system and/or aspects of the surrounding environment, prior to performing a baseline calibration, and may postpone the calibration and/or rejected using the sensor's output for the calibration.
Patent expiration dates:
- February 19, 2034✓✓
- February 19, 2034
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Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide
Patent 9279794*PED
Issued: March 8, 2016
Inventor(s): Tolmie Craig R. & Milsap Jeff & Acker Jaron M.
Assignee(s): Mallinckrodt Hospital Products IP LimitedDescribed are systems and methods for compensating long term sensitivity drift of catalytic type electrochemical gas sensors used in systems for delivering therapeutic nitric oxide (NO) gas to a patient by compensating for drift that may be specific to the sensors atypical use in systems for delivering therapeutic nitric oxide gas to a patient. In at least some instances, the long term sensitivity drift of catalytic type electrochemical gas sensors can be addressed using calibration schedules, which can factor in the absolute change in set dose of NO being delivered to the patient that can drive one or more baseline calibrations. The calibration schedules can be used reduce the amount of times the sensor goes offline. Systems and methods described may factor in in actions occurring at the delivery system and/or aspects of the surrounding environment, prior to performing a baseline calibration, and may postpone the calibration and/or rejected using the sensor's output for the calibration.
Patent expiration dates:
- August 19, 2034✓
- August 19, 2034
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Gas delivery device and system
Patent 9,295,802
Issued: March 29, 2016
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): Mallinckrodt Hospital Products IP LimitedA gas delivery system including a gas delivery device, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gas are also described.
Patent expiration dates:
- January 6, 2031✓✓
- January 6, 2031
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Gas delivery device and system
Patent 9295802*PED
Issued: March 29, 2016
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): Mallinckrodt Hospital Products IP LimitedA gas delivery system including a gas delivery device, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gas are also described.
Patent expiration dates:
- July 6, 2031✓
- July 6, 2031
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Nitric oxide delivery device
Patent 9,408,993
Issued: August 9, 2016
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): Mallinckrodt Hospital Products IP LimitedA nitric oxide delivery device including a valve assembly, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gases containing nitric oxide are also described.
Patent expiration dates:
- January 6, 2031✓✓
- January 6, 2031
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Nitric oxide delivery device
Patent 9408993*PED
Issued: August 9, 2016
Inventor(s): Bathe Duncan P. & Klaus John & Christensen David
Assignee(s): Mallinckrodt Hospital Products IP LimitedA nitric oxide delivery device including a valve assembly, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gases containing nitric oxide are also described.
Patent expiration dates:
- July 6, 2031✓
- July 6, 2031
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Apparatus and method for monitoring nitric oxide delivery
Patent 9,770,570
Issued: September 26, 2017
Inventor(s): Schnitman Robert & Medicis Joseph J. & Potenziano Jim & Acker Jaron & Schmidt Jeffrey
Assignee(s): Mallinckrodt Hospital Products IP LimitedDescribed is an apparatus for monitoring nitric oxide delivery, wherein such apparatus comprises an indicator to inform a user of the apparatus when the flow of breathing gas rises above or falls below a predetermined level or range. Also described is a method of monitoring nitric oxide delivery, wherein the flow of breathing gas is measured and displayed. In some embodiments, an alert is provided when the flow of breathing gas rises above or falls below a predetermined level or range.
Patent expiration dates:
- May 3, 2036✓
- May 3, 2036
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Apparatus and method for monitoring nitric oxide delivery
Patent 9770570*PED
Issued: September 26, 2017
Inventor(s): Schnitman Robert & Medicis Joseph J. & Potenziano Jim & Acker Jaron & Schmidt Jeffrey
Assignee(s): Mallinckrodt Hospital Products IP LimitedDescribed is an apparatus for monitoring nitric oxide delivery, wherein such apparatus comprises an indicator to inform a user of the apparatus when the flow of breathing gas rises above or falls below a predetermined level or range. Also described is a method of monitoring nitric oxide delivery, wherein the flow of breathing gas is measured and displayed. In some embodiments, an alert is provided when the flow of breathing gas rises above or falls below a predetermined level or range.
Patent expiration dates:
- November 3, 2036✓
- November 3, 2036
More about INOmax (nitric oxide)
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Glossary
Term | Definition |
---|---|
Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
AA | Products in conventional dosage forms not presenting bioequivalence problems. Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved. |
Further information
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