Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084999
Company: CARACO
Company: CARACO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| WYGESIC | ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE | 650MG;65MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/03/1976 | 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 |
|---|---|---|---|---|---|
| 09/01/1989 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/01/1989 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/01/1989 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/01/1989 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/01/1989 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/20/1990 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 12/06/1983 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/06/1983 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |