Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085418
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM BUTABARBITAL | BUTABARBITAL SODIUM | 15MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/15/1977 | 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 |
|---|---|---|---|---|---|
| 03/28/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 03/16/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 11/08/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |