Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074224
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRIAZOLAM | TRIAZOLAM | 0.125MG | TABLET;ORAL | Discontinued | None | No | No |
TRIAZOLAM | TRIAZOLAM | 0.25MG | TABLET;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 |
---|---|---|---|---|---|---|---|
06/01/1994 | 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 |
---|---|---|---|---|---|
06/28/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
01/03/2022 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
01/03/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
04/14/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
04/14/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
01/04/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
09/14/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
12/16/1997 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
08/28/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/13/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |