Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076201
Company: DEXCEL LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLOFENAC SODIUM DICLOFENAC SODIUM 100MG TABLET, EXTENDED RELEASE;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
11/06/2002 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
12/14/2014 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

07/06/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

07/31/2009 SUPPL-8 Labeling

Label is not available on this site.

11/29/2006 SUPPL-6 Labeling

Label is not available on this site.

03/13/2006 SUPPL-5 Labeling

Label is not available on this site.

10/23/2003 SUPPL-3 Labeling

Label is not available on this site.

DICLOFENAC SODIUM

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLOFENAC SODIUM DICLOFENAC SODIUM 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076201 DEXCEL LTD
DICLOFENAC SODIUM DICLOFENAC SODIUM 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075492 VPNA

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