Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074391
Company: ROXANE
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
DICLOFENAC SODIUM DICLOFENAC SODIUM 75MG 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
06/29/1995 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
09/22/2006 SUPPL-12 Labeling

Label is not available on this site.

11/09/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/2001 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/09/2001 SUPPL-9 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

11/09/2001 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

01/08/2002 SUPPL-7 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

01/08/2002 SUPPL-6 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

01/08/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/2001 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/22/1999 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/28/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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