Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
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 |
---|---|---|---|---|---|---|---|
10/30/1997 | 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 |
---|---|---|---|---|---|
02/29/2024 | SUPPL-39 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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02/29/2024 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/15/2023 | SUPPL-37 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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03/04/2021 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/08/2019 | SUPPL-35 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/21/2018 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-33 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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12/16/2016 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-31 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/18/2013 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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07/19/2011 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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12/19/2008 | SUPPL-19 | Labeling |
Label is not available on this site. |
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04/12/2001 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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03/21/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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08/21/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |