Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085964
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/18/1978 | 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 |
|---|---|---|---|---|---|
| 02/01/1991 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 08/01/1989 | SUPPL-44 | Labeling |
Label is not available on this site. |
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| 04/21/1989 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 04/21/1989 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 01/13/1988 | SUPPL-40 | Labeling |
Label is not available on this site. |