Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078957
Company: HETERO LABS LTD III
Company: HETERO LABS LTD III
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STAVUDINE | STAVUDINE | 15MG | CAPSULE;ORAL | Discontinued | None | No | No |
| STAVUDINE | STAVUDINE | 20MG | CAPSULE;ORAL | Discontinued | None | No | No |
| STAVUDINE | STAVUDINE | 30MG | CAPSULE;ORAL | Discontinued | None | No | No |
| STAVUDINE | STAVUDINE | 40MG | CAPSULE;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/2008/078957s000_TA_PEPFAR_Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078957s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/24/2015 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/02/2009 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/27/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |