Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Preferred Pharmaceuticals Inc.
791119022
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
791119022
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oseltamivir phosphate
Product Details
NDC Product Code
68788-8123Application Number
ANDA212784Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 22, 2023SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
OseltamivirActive
Code: 4A3O49NGEZClass: ACTIMQuantity: 6 mg in 1 mL
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT