Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079160
Company: ACTAVIS TOTOWA
Company: ACTAVIS TOTOWA
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-11 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
05/01/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
05/01/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
04/02/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
07/08/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
07/28/2016 | SUPPL-3 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
05/07/2015 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |