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 suspensionInitial U.S. Approval: 1999
Approved
Approval ID
b1abef84-d074-4872-9193-48a52cbabbd6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68788-7600
Application NumberANDA209113
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oseltamivir Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2023
FDA Product Classification
INGREDIENTS (8)
OSELTAMIVIR PHOSPHATEActive
Quantity: 6 mg in 1 mL
Code: 4A3O49NGEZ
Classification: ACTIM
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MONOSODIUM CITRATEInactive
Code: 68538UP9SE
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT