Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072370
Company: WATSON LABS INC
Company: WATSON LABS INC
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 |
---|---|---|---|---|---|---|---|
01/29/1993 | 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 |
---|---|---|---|---|---|
08/10/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
01/17/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
08/26/2021 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/072370s009lbl.pdf | |
08/26/2021 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
02/08/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
12/16/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
08/15/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/15/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/15/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
08/15/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/23/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/26/2021 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/072370s009lbl.pdf |