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Drugs@FDA: FDA-Approved Drugs

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

Products on ANDA 075185

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075185

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.

Therapeutic Equivalents for ANDA 075185

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	216548	RUBICON
DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	077863	UNIQUE

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	216548	RUBICON
DICLOFENAC SODIUM	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	090066	UNIQUE

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	216548	RUBICON
DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	090066	UNIQUE

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