Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206776
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | 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 |
|---|---|---|---|---|---|---|---|
| 05/23/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/04/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/22/2019 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/03/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |