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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 22, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Oseltamivir(6 mg in 1 mL)

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
68788-8123
Application Number
ANDA212784
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 22, 2023
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
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
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