Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090066
Company: UNIQUE PHARM LABS
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 No
DICLOFENAC SODIUM DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE;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
12/01/2010 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-4 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/22/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

10/15/2014 SUPPL-1 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

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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