Drugs@FDA: FDA-Approved Drugs
Company: SPECGX LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/24/1985 | 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 |
|---|---|---|---|---|---|
| 10/18/2013 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/20/2012 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/10/2006 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 10/21/2002 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 08/26/2002 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/26/2002 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/26/2000 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/19/1998 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 11/23/1998 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 11/23/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/29/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/13/1994 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 03/16/1994 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 05/27/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 07/16/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 11/21/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 08/24/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 09/03/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/18/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 06/20/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/03/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |