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 useInitial U.S. Approval: 1994
Approved
Approval ID
10a70995-e04d-4044-b1dc-c9aa27460397
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 3, 2020
Manufacturers
FDA
Sagent Pharmaceuticals
DUNS: 796852890
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 Code25021-204
Application NumberANDA091106
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vinorelbine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 3, 2020
FDA Product Classification
INGREDIENTS (2)
waterInactive
Code: 059QF0KO0R
Classification: IACT
vinorelbine tartrateActive
Quantity: 10 mg in 1 mL
Code: 253GQW851Q
Classification: ACTIM