Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072710
Company: EPIC PHARMA
Company: EPIC PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SULINDAC | SULINDAC | 150MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
03/25/1991 | 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 |
---|---|---|---|---|---|
04/28/2021 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
05/09/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
05/28/2015 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
07/15/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
10/01/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
05/13/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/12/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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03/17/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
05/31/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |
SULINDAC
TABLET;ORAL; 150MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SULINDAC | SULINDAC | 150MG | TABLET;ORAL | Prescription | No | AB | 072710 | EPIC PHARMA |
SULINDAC | SULINDAC | 150MG | TABLET;ORAL | Prescription | No | AB | 072050 | SUN PHARM INDUSTRIES |
SULINDAC | SULINDAC | 150MG | TABLET;ORAL | Prescription | No | AB | 071891 | WATSON LABS |