Vinorelbine
These highlights do not include all the information needed to use VINORELBINE INJECTION safely and effectively. See full prescribing information for VINORELBINE INJECTION. VINORELBINE injection, for intravenous use Initial U.S. Approval: 1994
Approved
Approval ID
dd3dcc9a-e40c-4677-9ee6-f318e7c7d835
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2022
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Vinorelbine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code45963-607
Application NumberANDA078011
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vinorelbine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
VINORELBINE TARTRATEActive
Quantity: 10 mg in 1 mL
Code: 253GQW851Q
Classification: ACTIM