Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIFLUNISAL | DIFLUNISAL | 500MG | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/31/1992 | 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-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
05/09/2016 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/14/2006 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
04/25/2006 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
03/08/2006 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
03/08/2002 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/08/2001 | SUPPL-21 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
03/08/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/02/1999 | SUPPL-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/02/1999 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
02/12/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/12/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/09/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
06/16/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/31/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/16/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/24/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/04/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
08/23/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/20/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/04/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
08/18/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |
DIFLUNISAL
TABLET;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIFLUNISAL | DIFLUNISAL | 500MG | TABLET;ORAL | Prescription | No | AB | 202845 | HERITAGE PHARMA |
DIFLUNISAL | DIFLUNISAL | 500MG | TABLET;ORAL | Prescription | No | AB | 073673 | TEVA |
DIFLUNISAL | DIFLUNISAL | 500MG | TABLET;ORAL | Prescription | No | AB | 203547 | ZYDUS PHARMS |