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FDA ANDA · ANDA091365

GEMCITABINE

gemcitabine hydrochloride

Sponsor: DR REDDYS LABS LTD

APPLICATION
ANDA091365
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-25
LATEST ACTION
2024-09-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

GEMCITABINE HYDROCHLORIDEPrescription
GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDEPrescription
GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2024-09-24Labeling · Supplement 13 · standardAP
2019-10-03Labeling · Supplement 8 · standardAP
2019-05-01Labeling · Supplement 7 · standardAP
2016-01-26Labeling · Supplement 4 · standardAP
2016-01-26Labeling · Supplement 5 · standardAP
2016-01-26Labeling · Supplement 3 · standardAP
2011-07-25OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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