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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075281
Company: AUROBINDO PHARMA USA

Products on ANDA 075281

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No
DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075281

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/2002	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
12/31/2025	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/21/2024	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/29/2021	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/28/2014	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
03/19/2010	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/20/2007	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075281

DICLOFENAC SODIUM

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	075281	AUROBINDO PHARMA USA
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 RESEARCH
DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	219945	UMEDICA
DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	090066	UNIQUE

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	075281	AUROBINDO PHARMA USA
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 RESEARCH
DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	219945	UMEDICA
DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	077863	UNIQUE

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