Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079054
Company: TORRENT PHARMS
Company: TORRENT PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALFUZOSIN HYDROCHLORIDE | ALFUZOSIN HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/18/2011 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079054s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/15/2022 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/07/2018 | SUPPL-15 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/15/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/15/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/15/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/11/2013 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |