Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087653
Company: MUTUAL PHARM
Company: MUTUAL PHARM
| 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 |
|---|---|---|---|---|---|---|---|
| 04/13/1982 | 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 |
|---|---|---|---|---|---|
| 12/01/1998 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/24/1996 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 12/23/1994 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/27/1991 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 05/31/1990 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 01/17/1989 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 04/22/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/19/1987 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/19/1987 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/19/1987 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/19/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/06/1987 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/01/1987 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/19/1986 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/19/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/19/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/01/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |