Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 075229
Company: RUBICON

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
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	TABLET;ORAL	Prescription	AB	No	No

Showing 1 to 2 of 2 entries

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
11/20/1998	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.

Showing 1 to 1 of 1 entries

Action Date	Submission	Supplement Categories or Approval Type	Note
11/21/2024	SUPPL-35	Labeling-Package Insert	Label is not available on this site.
04/28/2021	SUPPL-23	Labeling-Package Insert	Label is not available on this site.
04/26/2021	SUPPL-20	Labeling-Package Insert	Label is not available on this site.
12/06/2014	SUPPL-16	Labeling-Package Insert	Label is not available on this site.
09/04/2009	SUPPL-14	Labeling-Package Insert	Label is not available on this site.
04/29/2008	SUPPL-12	Labeling	Label is not available on this site.
10/05/2006	SUPPL-11	Labeling	Label is not available on this site.
10/02/2002	SUPPL-5	Manufacturing (CMC)-Packaging	Label is not available on this site.
10/02/2002	SUPPL-4	Manufacturing (CMC)-Control	Label is not available on this site.
10/02/2002	SUPPL-3	Manufacturing (CMC)-Facility	Label is not available on this site.
09/10/2002	SUPPL-6	Labeling	Label is not available on this site.
03/18/2002	SUPPL-2	Manufacturing (CMC)-Facility	Label is not available on this site.
03/18/2002	SUPPL-1	Manufacturing (CMC)-Packaging	Label is not available on this site.

Showing 1 to 13 of 13 entries

TABLET;ORAL; 50MG
TE Code = AB

CSV Excel Print

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	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

Showing 1 to 7 of 7 entries

TABLET;ORAL; 25MG
TE Code = AB

CSV Excel Print

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
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	215787	SENORES PHARMS

Showing 1 to 3 of 3 entries