Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074376
Company: CASI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLOFENAC SODIUM DICLOFENAC SODIUM 25MG TABLET, DELAYED RELEASE;ORAL Prescription AB No Yes
DICLOFENAC SODIUM DICLOFENAC SODIUM 50MG 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
09/28/1995 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
05/09/2016 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

11/26/2014 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

04/09/2009 SUPPL-31 Labeling

Label is not available on this site.

02/26/2009 SUPPL-30 Labeling

Label is not available on this site.

01/16/2008 SUPPL-25 Labeling

Label is not available on this site.

10/02/2006 SUPPL-23 Labeling

Label is not available on this site.

09/05/2002 SUPPL-19 Labeling

Label is not available on this site.

07/18/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/2002 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/16/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/04/1999 SUPPL-6 Labeling

Label is not available on this site.

03/04/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/28/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/13/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/10/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/16/1996 SUPPL-1 Labeling

Label is not available on this site.

DICLOFENAC SODIUM

TABLET, DELAYED RELEASE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLOFENAC SODIUM DICLOFENAC SODIUM 25MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075185 CARLSBAD
DICLOFENAC SODIUM DICLOFENAC SODIUM 25MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 074376 CASI PHARMS INC
DICLOFENAC SODIUM DICLOFENAC SODIUM 25MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 090066 UNIQUE PHARM LABS

TABLET, DELAYED RELEASE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLOFENAC SODIUM DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 074514 ACTAVIS ELIZABETH
DICLOFENAC SODIUM DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075185 CARLSBAD
DICLOFENAC SODIUM DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 074376 CASI PHARMS INC
DICLOFENAC SODIUM DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075281 MYLAN PHARMS INC
DICLOFENAC SODIUM DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 090066 UNIQUE PHARM LABS

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