Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074312
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALPRAZOLAM | ALPRAZOLAM | 1MG/ML | CONCENTRATE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/31/1993 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/074312.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/18/2023 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/16/2021 | SUPPL-16 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/31/2017 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/28/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/05/2001 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/27/2001 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/21/2001 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/12/1997 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |