Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075185
Company: CARLSBAD

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 No
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
11/13/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75185ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/29/2021 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
04/29/2021 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
04/20/2021 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
05/09/2016 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
08/24/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
02/18/2010 SUPPL-8 Labeling

Label is not available on this site.
02/23/2006 SUPPL-5 Labeling

Label is not available on this site.
11/19/2003 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 PHARM LABS

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 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 090066 UNIQUE PHARM LABS

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