Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077094
Company: ZYDUS PHARMS USA
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 No
RIBAVIRIN RIBAVIRIN 500MG 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
12/05/2005 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077094TA_ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/25/2015 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

05/04/2015 SUPPL-21 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/04/2015 SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/10/2011 SUPPL-19 REMS-Modified

Label is not available on this site.

03/10/2011 SUPPL-18 REMS-Proposal

Label is not available on this site.

09/16/2010 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/23/2008 SUPPL-15 Labeling

Label is not available on this site.

05/14/2008 SUPPL-14 Labeling

Label is not available on this site.

01/04/2008 SUPPL-12 Labeling

Label is not available on this site.

04/18/2008 SUPPL-11 Labeling

Label is not available on this site.

09/11/2014 SUPPL-7 Labeling

Label is not available on this site.

03/20/2008 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/10/2007 SUPPL-5 Labeling

Label is not available on this site.

03/16/2007 SUPPL-2 Labeling

Label is not available on this site.

03/16/2007 SUPPL-1 Manufacturing (CMC)-New Strength

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

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RIBAVIRIN RIBAVIRIN 500MG TABLET;ORAL Prescription No AB 202546 BEXIMCO PHARMS USA
RIBAVIRIN RIBAVIRIN 500MG TABLET;ORAL Prescription No AB 077094 ZYDUS PHARMS USA

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