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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
August 5, 2021
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.

CADILA HEALTHCARE LIMITED

Cadila Healthcare Limited

677605858

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
70771-1598
Application Number
ANDA209113
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 5, 2021
SORBITOLInactive
Code: 506T60A25RClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
Code: 4A3O49NGEZClass: ACTIMQuantity: 6 mg in 1 mL
MONOSODIUM CITRATEInactive
Code: 68538UP9SEClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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