Drugs@FDA: FDA-Approved Drugs
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/02/1981 | 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 |
|---|---|---|---|---|---|
| 12/21/1999 | SUPPL-37 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 05/20/1999 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1999 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/01/1998 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/26/1997 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 06/26/1997 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/26/1997 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/26/1997 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/26/1997 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1994 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/24/1994 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/29/1992 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/29/1992 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1991 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/17/1989 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 05/13/1988 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/30/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/20/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/20/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/31/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/29/1983 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |