Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077743
Company: SANDOZ

Products on ANDA 077743

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIBAVIRIN	RIBAVIRIN	200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077743

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.

Therapeutic Equivalents for ANDA 077743

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	077743	SANDOZ
RIBAVIRIN	RIBAVIRIN	200MG	TABLET;ORAL	Prescription	No	AB	077094	ZYDUS PHARMS USA