Drugs@FDA: FDA-Approved Drugs
Company: IVAX SUB TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXAZEPAM | OXAZEPAM | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/03/1987 | 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 |
|---|---|---|---|---|---|
| 02/05/2021 | SUPPL-34 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-33 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/06/2006 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 07/29/2002 | SUPPL-24 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/12/2001 | SUPPL-23 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/11/2000 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/11/2000 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/11/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1999 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/11/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/01/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/02/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |