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FDA Approval

Oseltamivir Phosphate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
September 30, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Oseltamivir(6 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Amneal Pharmaceuticals of New York, LLC

Amneal Pharmaceuticals NY LLC

123797875

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
69238-1273
Application Number
ANDA210186
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 30, 2023
MONOSODIUM CITRATEInactive
Code: 68538UP9SEClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: 4A3O49NGEZClass: ACTIMQuantity: 6 mg in 1 mL
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
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