Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073262
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SULINDAC | SULINDAC | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| SULINDAC | SULINDAC | 150MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/06/1991 | 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 |
|---|---|---|---|---|---|
| 05/07/2021 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/24/2009 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 12/20/2007 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 06/23/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/05/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/05/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/17/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |