Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076152
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLOFENAC SODIUM DICLOFENAC SODIUM 100MG TABLET, EXTENDED 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
12/13/2001 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
01/24/2017 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

01/24/2017 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/29/2010 SUPPL-8 Labeling-Container/Carton Labels

Label is not available on this site.

10/25/2007 SUPPL-3 Labeling

Label is not available on this site.

06/15/2006 SUPPL-2 Labeling

Label is not available on this site.

06/12/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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