Drugs@FDA: FDA-Approved Drugs
Company: ACI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 03/27/1979 | 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 |
|---|---|---|---|---|---|
| 03/12/1999 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/09/1996 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/09/1996 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/28/1996 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/09/1996 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 09/09/1996 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/15/1995 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 09/28/1994 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 12/16/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 10/03/1990 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 02/13/1991 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1991 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 07/13/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 05/13/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/13/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/08/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/08/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/10/1984 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |