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Oseltamivir phosphate

These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION. OSELTAMIVIR PHOSPHATE for oral suspension Initial U.S. Approval: 1999

Approved
Approval ID

c6f78d2d-6452-4af3-83c6-b044d1604bdc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 31, 2023

Manufacturers
FDA

Ajanta Pharma USA Inc.

DUNS: 557554156

Products 1

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 Code27241-139
Application NumberANDA212784
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 31, 2023
Generic NameOseltamivir phosphate

INGREDIENTS (7)

OSELTAMIVIR PHOSPHATEActive
Quantity: 6 mg in 1 mL
Code: 4A3O49NGEZ
Classification: ACTIM
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

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Oseltamivir phosphate - FDA Drug Approval Details