Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079117
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;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
09/17/2009 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
01/11/2016 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

05/19/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

05/19/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

05/19/2014 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

11/16/2011 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified

Label is not available on this site.

04/02/2010 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

RIBAVIRIN

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REBETOL RIBAVIRIN 200MG CAPSULE;ORAL Prescription Yes AB 020903 MERCK SHARP DOHME
RIBASPHERE RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 076203 KADMON PHARMS LLC
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 079117 AUROBINDO PHARMA
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 076277 TEVA
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 077224 ZYDUS PHARMS USA

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