Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077743
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIBAVIRIN RIBAVIRIN 200MG 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
10/03/2006 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
01/09/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/09/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

11/30/2011 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/27/2008 SUPPL-4 Labeling

Label is not available on this site.

03/05/2008 SUPPL-3 Labeling

Label is not available on this site.

03/20/2008 SUPPL-1 Manufacturing (CMC)-Control

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

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