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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
January 5, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Oseltamivir(75 mg in 1 1)

Manufacturing Establishments1

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

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

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
68071-2612
Application Number
ANDA212544
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 5, 2022
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
SHELLACInactive
Code: MB5IUD6JUAClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
Code: 4A3O49NGEZClass: ACTIMQuantity: 75 mg in 1 1
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
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