Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087433
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;15MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/22/1981 | 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 |
|---|---|---|---|---|---|
| 10/14/1988 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/19/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/18/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |