Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088354
Company: DURAMED PHARMS BARR
Company: DURAMED PHARMS BARR
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 |
---|---|---|---|---|---|---|---|
02/06/1984 | 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 |
---|---|---|---|---|---|
03/18/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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11/30/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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03/18/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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06/11/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |