STERILE WATER FOR INHALATION
sterile water for inhalation inhalant
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
Item Code (Source)
NDC:78718-000
Route of Administration
RESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)
WATER
1 g in 1 mL
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:78718-000-01
500 mL in 1 BAG; Type 0: Not a Combination Product
04/30/2021
2
NDC:78718-000-00
1000 mL in 1 BAG; Type 0: Not a Combination Product
04/30/2021
3
NDC:78718-000-02
2000 mL in 1 BAG; Type 0: Not a Combination Product
04/30/2021
4
NDC:78718-000-21
250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
11/16/2021
5
NDC:78718-000-23
500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
11/16/2021
6
NDC:78718-000-25
1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
11/16/2021
7
NDC:78718-000-27
2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
12/03/2021
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
unapproved drug other
04/30/2021
Labeler - SENSIMEDICAL LLC
(117526048)
Establishment
Name
Address
ID/FEI
Business Operations
Laboratorios Biogalenic
851259507
manufacture(78718-000) , api manufacture(78718-000)
Sterile water Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for sterile water.
M-M-R Ii (Measles, Mumps and Rubella Virus Vaccine Live) - Merck Sharp & Dohme LLC
