Drugs@FDA: FDA-Approved Drugs
Company: HIKMA INTL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTALBITAL, ASPIRIN AND CAFFEINE | ASPIRIN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 06/05/1979 | 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 |
|---|---|---|---|---|---|
| 06/24/1999 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/01/1998 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/17/1997 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/17/1997 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/17/1997 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/17/1997 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/17/1997 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/12/1996 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/29/1996 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/23/1996 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/30/1992 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 01/31/1991 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/10/1989 | SUPPL-29 | Bioequivalence |
Label is not available on this site. |
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| 05/24/1989 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 05/24/1989 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/02/1989 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 11/17/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/17/1988 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 11/17/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/17/1988 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/17/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/23/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/23/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/23/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/16/1984 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/18/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |