Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070628
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 80MG/ML;16MG/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 |
---|---|---|---|---|---|---|---|
04/30/1987 | 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 |
---|---|---|---|---|---|
07/13/2023 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
07/13/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
11/05/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/22/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
08/11/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/28/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/23/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
03/14/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/25/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |