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 | 300MG;60MG | 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 |
---|---|---|---|---|---|---|---|
02/25/1986 | 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-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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07/31/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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05/07/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
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05/07/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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05/07/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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05/07/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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05/07/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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05/30/1995 | SUPPL-12 | Labeling |
Label is not available on this site. |
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07/20/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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10/21/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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06/20/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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06/20/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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02/18/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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09/16/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
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06/04/1987 | 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. |