Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076561
Company: AMICI PHARMA

Products on ANDA 076561

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CATAFLAM	DICLOFENAC POTASSIUM	50MG	TABLET;ORAL	Prescription	AB	No	No
CATAFLAM	DICLOFENAC POTASSIUM	25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076561

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/18/2004	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
11/21/2024	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
05/17/2021	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/29/2021	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/12/2021	SUPPL-11	Labeling-Container/Carton Labels		Label is not available on this site.
05/17/2021	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
05/17/2021	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/14/2014	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/12/2010	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
02/25/2009	SUPPL-6	Labeling		Label is not available on this site.
03/17/2006	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076561

CATAFLAM

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CATAFLAM	DICLOFENAC POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	076561	AMICI PHARMA
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	215585	INGENUS PHARMS LLC
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	075463	RK PHARMA
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	075229	RUBICON RESEARCH
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	215787	SENORES PHARMS
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	075219	TEVA
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	215750	UMEDICA

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CATAFLAM	DICLOFENAC POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	076561	AMICI PHARMA
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	075229	RUBICON RESEARCH
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	215787	SENORES PHARMS
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	215750	UMEDICA