Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075590
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NABUMETONE | NABUMETONE | 500MG | TABLET;ORAL | Discontinued | None | No | No |
NABUMETONE | NABUMETONE | 750MG | 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 |
---|---|---|---|---|---|---|---|
02/25/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75590TA.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
05/09/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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09/09/2002 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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09/09/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/09/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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11/08/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/08/2002 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |