Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075229
Company: CASI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription AB 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
11/20/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75229ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/06/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

09/04/2009 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

04/29/2008 SUPPL-12 Labeling

Label is not available on this site.

10/05/2006 SUPPL-11 Labeling

Label is not available on this site.

09/10/2002 SUPPL-6 Labeling

Label is not available on this site.

10/02/2002 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/02/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

03/18/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

03/18/2002 SUPPL-1 Manufacturing (CMC)-Packaging

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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