U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077863
Company: UNIQUE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLOFENAC SODIUM DICLOFENAC SODIUM 75MG TABLET, DELAYED 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
06/08/2007 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-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/29/2021 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/22/2014 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

03/17/2011 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/04/2009 SUPPL-3 Labeling

Label is not available on this site.

DICLOFENAC SODIUM

TABLET, DELAYED RELEASE;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLOFENAC SODIUM DICLOFENAC SODIUM 75MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 074514 ACTAVIS ELIZABETH
DICLOFENAC SODIUM DICLOFENAC SODIUM 75MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075185 CARLSBAD
DICLOFENAC SODIUM DICLOFENAC SODIUM 75MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 077863 UNIQUE
Back to Top