Generic Trandate Availability
Last updated on Oct 9, 2024.
Trandate is a brand name of labetalol, approved by the FDA in the following formulation(s):
TRANDATE (labetalol hydrochloride - injectable;injection)
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Manufacturer: SEBELA IRELAND LTD
Approval date: December 31, 1985
Strength(s): 5MG/ML (discontinued) [RLD] [AP]
TRANDATE (labetalol hydrochloride - tablet;oral)
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Manufacturer: ALVOGEN
Approval date: August 1, 1984
Strength(s): 200MG (discontinued) [RLD] [AB], 300MG (discontinued) [RLD] [AB], 400MG (discontinued) [RLD] [AB] -
Manufacturer: ALVOGEN
Approval date: May 24, 1985
Strength(s): 100MG (discontinued) [RLD] [AB]
All of the above formulations have been discontinued.
Has a generic version of Trandate been approved?
Yes. The following products are equivalent to Trandate:
labetalol hydrochloride injectable;injection
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Manufacturer: BAXTER HLTHCARE CORP
Approval date: July 5, 2002
Strength(s): 5MG/ML [AP] -
Manufacturer: CAPLIN
Approval date: September 7, 2021
Strength(s): 5MG/ML [AP] -
Manufacturer: GLAND PHARMA LTD
Approval date: April 3, 2012
Strength(s): 5MG/ML [AP] -
Manufacturer: HIKMA
Approval date: May 28, 1999
Strength(s): 5MG/ML [AP] -
Manufacturer: HOSPIRA
Approval date: November 29, 1999
Strength(s): 5MG/ML [AP], 5MG/ML [AP] -
Manufacturer: RISING
Approval date: November 29, 1999
Strength(s): 5MG/ML [AP]
labetalol hydrochloride tablet;oral
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Manufacturer: ANDAS 5 HOLDING
Approval date: July 29, 1999
Strength(s): 100MG [AB], 200MG [AB], 300MG [AB] -
Manufacturer: APPCO
Approval date: June 20, 2018
Strength(s): 100MG [AB], 200MG [AB], 300MG [AB] -
Manufacturer: CADILA PHARMS LTD
Approval date: May 13, 2019
Strength(s): 100MG [AB], 200MG [AB], 300MG [AB] -
Manufacturer: ENDO OPERATIONS
Approval date: July 10, 2012
Strength(s): 100MG [AB], 200MG [AB], 300MG [AB] -
Manufacturer: EPIC PHARMA LLC
Approval date: September 30, 2020
Strength(s): 100MG [AB], 200MG [AB], 300MG [AB] -
Manufacturer: HERITAGE PHARMA
Approval date: August 3, 1998
Strength(s): 100MG [AB], 200MG [AB], 300MG [AB] -
Manufacturer: HIBROW HLTHCARE
Approval date: February 4, 2019
Strength(s): 100MG [AB], 200MG [AB], 300MG [AB] -
Manufacturer: RUBICON
Approval date: August 18, 2021
Strength(s): 100MG [AB], 200MG [AB], 300MG [AB] -
Manufacturer: SANDOZ
Approval date: August 4, 1998
Strength(s): 100MG [AB], 200MG [AB], 300MG [AB] -
Manufacturer: WATSON LABS
Approval date: August 3, 1998
Strength(s): 100MG [AB], 200MG [AB], 300MG [AB] -
Manufacturer: ZYDUS PHARMS
Approval date: September 19, 2017
Strength(s): 100MG [AB], 200MG [AB], 300MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Trandate. 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.
More about Trandate (labetalol)
- Check interactions
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- Drug images
- Side effects
- Dosage information
- During pregnancy
- Drug class: non-cardioselective beta blockers
- Breastfeeding
Patient resources
- Trandate drug information
- Trandate (Labetalol Intravenous) (Advanced Reading)
- Trandate (Labetalol Oral) (Advanced Reading)
- Trandate (Labetalol Tablets)
Other brands
Professional resources
Related treatment guides
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. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
AP | Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.