Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084656
Company: ROXANE
Company: ROXANE
| 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 |
|---|---|---|---|---|---|---|---|
| 05/10/1976 | 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 |
|---|---|---|---|---|---|
| 12/28/2000 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/28/1996 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/15/1995 | SUPPL-48 | Labeling |
Label is not available on this site. |
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| 09/28/1994 | SUPPL-47 | Labeling |
Label is not available on this site. |
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| 12/16/1993 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 10/03/1990 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 12/05/1989 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 01/03/1989 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/01/1989 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 04/06/1984 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |