gemcitabine hydrochloride

Product NDC

45963-612

11-digit product format

459630612

Labeler code

45963

Product ID

45963-612_f7af83fb-a439-4d8b-ba1a-fddbd803642c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

gemcitabine hydrochloride

Dosage form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route

INTRAVENOUS

Labeler

Actavis Pharma, Inc.

Application

ANDA079160

Marketing category

ANDA

Marketing start

2015-02-02

Marketing end

2020-10-31

Substance

GEMCITABINE HYDROCHLORIDE

Active strength

200 mg/5mL

Pharmacologic classes

Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record