Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090084
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYCODONE AND ASPIRIN | ASPIRIN; OXYCODONE HYDROCHLORIDE | 325MG;4.8355MG | 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 |
---|---|---|---|---|---|---|---|
03/22/2011 | 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 |
---|---|---|---|---|---|
05/03/2021 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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03/04/2021 | SUPPL-10 | Labeling-Medication Guide, 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, Labeling-Medication Guide |
Label is not available on this site. |
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09/11/2018 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-5 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |