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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076561
Company: AMICI
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
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
05/17/2021 SUPPL-13 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

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.

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
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 075219 TEVA
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription No AB 215750 UMEDICA LABS PVT LTD

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
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