Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYCODONE AND ASPIRIN | ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE | 325MG;4.5MG;0.38MG | 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 |
---|---|---|---|---|---|---|---|
07/17/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40260ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/04/2021 | SUPPL-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
03/04/2021 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/09/2019 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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09/20/2018 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
09/18/2018 | SUPPL-15 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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03/07/2017 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/16/2016 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/16/2016 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
07/24/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/08/2002 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
09/24/2001 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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11/02/2001 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/18/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/18/2000 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/18/2000 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/18/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |