Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200145
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/25/2011 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2020 SUPPL-12 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/03/2019 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

05/03/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

06/30/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/30/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

06/30/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

06/30/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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