Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089080
Company: PUREPAC PHARM
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 | 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 |
---|---|---|---|---|---|---|---|
07/17/1986 | 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 |
---|---|---|---|---|---|
04/16/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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12/12/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
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06/29/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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06/29/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |