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
9fb09e82-42ef-4a2a-9bcd-3aab3ac52bb3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
Exelan Pharmaceuticals, Inc.
DUNS: 967795266
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 Code76282-739
Application NumberANDA212858
Product Classification
M
Marketing Category
C73584
G
Generic Name
OSELTAMIVIR PHOSPHATE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (8)
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
OSELTAMIVIR PHOSPHATEActive
Quantity: 6 mg in 1 mL
Code: 4A3O49NGEZ
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MONOSODIUM CITRATEInactive
Code: 68538UP9SE
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT