Drugs@FDA: FDA-Approved Drugs
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG/5ML;5MG/5ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
12/18/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203573Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/18/2024 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
12/18/2023 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/18/2023 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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03/04/2021 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
10/08/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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10/08/2019 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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09/21/2018 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
09/18/2018 | SUPPL-6 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
12/16/2016 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/16/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |