Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073039
Company: RISING PHARMA
Company: RISING PHARMA
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 |
---|---|---|---|---|---|---|---|
06/22/1993 | 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 |
---|---|---|---|---|---|
04/28/2021 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
05/09/2016 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
12/22/2015 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
08/13/2010 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
05/08/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
05/16/2006 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
09/18/2002 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
02/05/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/18/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |