Drugs@FDA: FDA-Approved Drugs
Company: MIKART
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 650MG;30MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/03/1986 | 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 |
|---|---|---|---|---|---|
| 08/13/2002 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 10/21/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/31/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/08/1996 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/08/1996 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/08/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/14/1995 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/30/1995 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 02/08/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/08/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 07/11/1989 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/21/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/23/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/20/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/20/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/02/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 02/08/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 02/08/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/16/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/14/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/14/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/06/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |