Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077983
Company: TEVA PHARMS
Company: TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 200MG 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 |
---|---|---|---|---|---|---|---|
01/25/2011 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077983s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/077983s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/18/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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09/06/2011 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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08/30/2011 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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05/18/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |