Drugs@FDA: FDA-Approved Drugs
Company: AUROBINDO PHARMA USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TEMAZEPAM | TEMAZEPAM | 30MG | CAPSULE;ORAL | Discontinued | None | No | No |
| TEMAZEPAM | TEMAZEPAM | 7.5MG | CAPSULE;ORAL | Discontinued | None | No | No |
| TEMAZEPAM | TEMAZEPAM | 22.5MG | CAPSULE;ORAL | Discontinued | None | No | No |
| TEMAZEPAM | TEMAZEPAM | 15MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/10/1986 | 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 |
|---|---|---|---|---|---|
| 05/21/2021 | SUPPL-33 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/26/2019 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/26/2019 | SUPPL-30 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/04/2016 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/21/2010 | SUPPL-24 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/070920Orig1s024Approv.pdf |
| 05/21/2010 | SUPPL-23 | Efficacy-New Dosing Regimen |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/070920Orig1s023Approv.pdf |
| 06/12/2009 | SUPPL-20 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/070920Orig1s020Approv.pdf |
| 06/12/2009 | SUPPL-19 | Efficacy-New Dosing Regimen |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/070920Orig1s019Approv.pdf |
| 09/25/2003 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/07/2001 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/01/2001 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/01/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/19/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/31/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/19/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/10/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/19/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |