Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077774
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STAVUDINE | STAVUDINE | 1MG/ML | FOR SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 12/29/2008 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077774ta-ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077774s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/31/2012 | SUPPL-6 | REMS-Modified, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/29/2011 | SUPPL-5 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2011 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2009 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |