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FDA ANDA · ANDA205242
GEMCITABINE
gemcitabine hydrochloride
Sponsor: MYLAN LABS LTD
APPLICATION
ANDA205242
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-06
LATEST ACTION
2025-08-04
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GEMCITABINE HYDROCHLORIDEPrescription
GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDEPrescription
GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDEPrescription
GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) · INJECTABLE · INJECTION
Approval history
2025-08-04Labeling · Supplement 9 · standardAP
2020-02-28Labeling · Supplement 4 · standardAP
2019-05-03Labeling · Supplement 1 · standardAP
2017-12-06UNKNOWN · Original · standardAP
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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