Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202063
Company: EMCURE PHARMS LTD
Company: EMCURE PHARMS 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/11/2012 | ORIG-1 | Approval | Not Applicable |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202063Orig1s000Approv.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/14/2019 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/14/2019 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/14/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/27/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/27/2015 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/27/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |