Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070296
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIAZEPAM | DIAZEPAM | 5MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 02/12/1986 | 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 |
|---|---|---|---|---|---|
| 12/16/2016 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/19/1999 | SUPPL-18 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 01/25/1999 | SUPPL-17 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/08/1994 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/09/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 02/21/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/02/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/25/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |