Drugs@FDA: FDA-Approved Drugs
Company: PUREPAC PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 05/11/1979 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/086681_acetaminophen_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/02/2001 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/18/2001 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/07/1998 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/18/1996 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/29/1994 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 09/08/1993 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/26/1991 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 11/15/1990 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 06/29/1989 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 07/03/1991 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/03/1991 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/10/1989 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/14/1985 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/12/1985 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/18/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/18/1984 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/18/1984 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/18/1984 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/06/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |