Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072902
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 600MG BASE | 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 |
---|---|---|---|---|---|---|---|
12/21/1990 | 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 |
---|---|---|---|---|---|
04/30/2021 | SUPPL-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
05/09/2016 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
08/16/2007 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
05/16/2000 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
05/16/2000 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/05/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/24/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/22/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/12/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/06/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |