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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075463
Company: RK PHARMA

Products on ANDA 075463

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075463

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/26/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75463ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/31/2021	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/14/2015	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/21/2009	SUPPL-11	Labeling		Label is not available on this site.
10/16/2007	SUPPL-6	Labeling		Label is not available on this site.
06/07/2006	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075463

DICLOFENAC POTASSIUM

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
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	215585	NOVAST LABS
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
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

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