Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076277
Company: TEVA
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
10/04/2004 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
02/24/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

02/24/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

09/26/2013 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/26/2013 SUPPL-8 Labeling-Medication Guide

Label is not available on this site.

04/07/2011 SUPPL-7 Labeling-Medication Guide, REMS-Proposal, Labeling-Package Insert

Label is not available on this site.

03/15/2011 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/26/2010 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/17/2008 SUPPL-4 Labeling

Label is not available on this site.

01/04/2008 SUPPL-3 Labeling

Label is not available on this site.

05/09/2007 SUPPL-1 Labeling

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 076192 CASI PHARMS INC
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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