Gemcitabine
These highlights do not include all the information needed to use GEMCITABINE INJECTION safely and effectively. See full prescribing information for GEMCITABINE INJECTION.GEMCITABINE injection, for intravenous use.Initial U.S. Approval: 1996
Approved
Approval ID
5b6be4b4-1f0a-4da2-b5d2-2592f401f90b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2020
Manufacturers
FDA
Armas Pharmaceuticals Inc.
DUNS: 098405973
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
GEMCITABINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72485-222
Application NumberANDA210991
Product Classification
M
Marketing Category
C73584
G
Generic Name
GEMCITABINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 10, 2020
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
GEMCITABINE HYDROCHLORIDEActive
Quantity: 1 g in 26.3 mL
Code: U347PV74IL
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT