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Drugs@FDA: FDA-Approved Drugs

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/20/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75229ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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.
09/10/2002 SUPPL-6 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.
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.

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

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
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
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