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. |
||
| 09/06/2011 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/30/2011 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |