Tamiflu
These highlights do not include all the information needed to use TAMIFLU safely and effectively. See full prescribing information for TAMIFLU. TAMIFLU (oseltamivir phosphate) capsules TAMIFLU (oseltamivir phosphate) for oral suspension Initial U.S. Approval: 1999
Approved
Approval ID
03a2a7f0-406c-4784-84c1-5fd5f5be4773
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code42254-092
Application NumberNDA021246
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oseltamivir Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2011
FDA Product Classification
INGREDIENTS (7)
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
sorbitolInactive
Code: 506T60A25R
Classification: IACT
monosodium citrateInactive
Code: 68538UP9SE
Classification: IACT
Oseltamivir PhosphateActive
Quantity: 6 mg in 1 mL
Code: 4A3O49NGEZ
Classification: ACTIM
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
SACCHARIN SODIUM DIHYDRATEInactive
Code: SB8ZUX40TY
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT