Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075463
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;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
07/26/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75463ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/14/2015 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/21/2009 SUPPL-11 Labeling

Label is not available on this site.

10/16/2007 SUPPL-6 Labeling

Label is not available on this site.

06/07/2006 SUPPL-4 Labeling

Label is not available on this site.

DICLOFENAC POTASSIUM

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription No AB 076561 AMICI
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription No AB 075229 CASI PHARMS INC
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription No AB 075463 MYLAN
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription No AB 075219 TEVA

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