Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077053
Company: TEVA
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
12/05/2005 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077053ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/30/2013 SUPPL-13 Labeling-Medication Guide

Label is not available on this site.

03/18/2011 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

01/10/2011 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/12/2011 SUPPL-10 REMS-Proposal

Label is not available on this site.

09/08/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

05/11/2010 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

03/08/2010 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

01/14/2009 SUPPL-6 Labeling

Label is not available on this site.

06/30/2008 SUPPL-5 Labeling

Label is not available on this site.

03/07/2008 SUPPL-4 Labeling

Label is not available on this site.

04/10/2006 SUPPL-1 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 077456 KADMON PHARMS LLC
RIBAVIRIN RIBAVIRIN 200MG TABLET;ORAL Prescription No AB 077743 SANDOZ
RIBAVIRIN RIBAVIRIN 200MG TABLET;ORAL Prescription No AB 202546 SANDOZ INC
RIBAVIRIN RIBAVIRIN 200MG TABLET;ORAL Prescription No AB 077053 TEVA
RIBAVIRIN RIBAVIRIN 200MG TABLET;ORAL Prescription No AB 077094 ZYDUS PHARMS USA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English