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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074376
Company: CHARTWELL RX

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLOFENAC SODIUM DICLOFENAC SODIUM 25MG TABLET, DELAYED RELEASE;ORAL Discontinued None No No
DICLOFENAC SODIUM DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE;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
09/28/1995 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
11/21/2024 SUPPL-43 Labeling-Package Insert

Label is not available on this site.
04/29/2021 SUPPL-42 Labeling-Package Insert

Label is not available on this site.
03/30/2021 SUPPL-38 Labeling-Package Insert

Label is not available on this site.
05/09/2016 SUPPL-37 Labeling-Package Insert

Label is not available on this site.
11/26/2014 SUPPL-35 Labeling-Package Insert

Label is not available on this site.
04/09/2009 SUPPL-31 Labeling

Label is not available on this site.
02/26/2009 SUPPL-30 Labeling

Label is not available on this site.
01/16/2008 SUPPL-25 Labeling

Label is not available on this site.
10/02/2006 SUPPL-23 Labeling

Label is not available on this site.
09/05/2002 SUPPL-19 Labeling

Label is not available on this site.
07/18/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
03/25/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
04/19/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
05/09/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
03/12/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
03/12/2002 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
08/16/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
09/14/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
03/04/1999 SUPPL-6 Labeling

Label is not available on this site.
03/04/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
01/28/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
06/13/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
06/10/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
09/16/1996 SUPPL-1 Labeling

Label is not available on this site.
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