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. |
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| 01/03/2022 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/03/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/14/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/14/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/04/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/14/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 12/16/1997 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 08/28/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/13/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |