Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079069
Company: MYLAN
Company: MYLAN
| 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 |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/02/2020 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/02/2020 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2012 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2011 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal |
Label is not available on this site. |
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| 04/07/2011 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |