Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077456
Company: KADMON PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIBAVIRIN RIBAVIRIN 200MG TABLET;ORAL Prescription AB No No
RIBAVIRIN RIBAVIRIN 400MG TABLET;ORAL Prescription AB No No
RIBAVIRIN RIBAVIRIN 600MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/05/2005 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
09/18/2017 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

02/06/2015 SUPPL-17 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/09/2014 SUPPL-14 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/23/2011 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

10/27/2010 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/29/2011 SUPPL-10 Labeling-Container/Carton Labels

Label is not available on this site.

02/11/2008 SUPPL-8 Labeling

Label is not available on this site.

06/18/2008 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

05/21/2009 SUPPL-6 Labeling

Label is not available on this site.

02/06/2006 SUPPL-3 Labeling

Label is not available on this site.

RIBAVIRIN

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RIBAVIRIN RIBAVIRIN 200MG TABLET;ORAL Prescription No AB 079111 AUROBINDO PHARMA
RIBAVIRIN RIBAVIRIN 200MG TABLET;ORAL Prescription No AB 202546 BEXIMCO PHARMS USA
RIBAVIRIN RIBAVIRIN 200MG TABLET;ORAL Prescription No AB 077456 KADMON PHARMS LLC
RIBAVIRIN RIBAVIRIN 200MG TABLET;ORAL Prescription No AB 077743 SANDOZ
RIBAVIRIN RIBAVIRIN 200MG TABLET;ORAL Prescription No AB 077053 TEVA
RIBAVIRIN RIBAVIRIN 200MG TABLET;ORAL Prescription No AB 077094 ZYDUS PHARMS USA

TABLET;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RIBAVIRIN RIBAVIRIN 400MG TABLET;ORAL Prescription No AB 202546 BEXIMCO PHARMS USA
RIBAVIRIN RIBAVIRIN 400MG TABLET;ORAL Prescription No AB 077456 KADMON PHARMS LLC
RIBAVIRIN RIBAVIRIN 400MG TABLET;ORAL Prescription No AB 077094 ZYDUS PHARMS USA

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RIBAVIRIN RIBAVIRIN 600MG TABLET;ORAL Prescription No AB 202546 BEXIMCO PHARMS USA
RIBAVIRIN RIBAVIRIN 600MG TABLET;ORAL Prescription No AB 077456 KADMON PHARMS LLC
RIBAVIRIN RIBAVIRIN 600MG TABLET;ORAL Prescription No AB 077094 ZYDUS PHARMS USA

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