Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077094
Company: ZYDUS PHARMS USA

Products on ANDA 077094

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIBAVIRIN	RIBAVIRIN	200MG	TABLET;ORAL	Prescription	AB	No	No
RIBAVIRIN	RIBAVIRIN	400MG	TABLET;ORAL	Discontinued	None	No	No
RIBAVIRIN	RIBAVIRIN	600MG	TABLET;ORAL	Discontinued	None	No	No
RIBAVIRIN	RIBAVIRIN	500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077094

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/2005/077094TA_ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2015	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
05/04/2015	SUPPL-21	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/04/2015	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/10/2011	SUPPL-19	REMS-Modified		Label is not available on this site.
03/10/2011	SUPPL-18	REMS-Proposal		Label is not available on this site.
09/16/2010	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/23/2008	SUPPL-15	Labeling		Label is not available on this site.
05/14/2008	SUPPL-14	Labeling		Label is not available on this site.
01/04/2008	SUPPL-12	Labeling		Label is not available on this site.
04/18/2008	SUPPL-11	Labeling		Label is not available on this site.
09/11/2014	SUPPL-7	Labeling		Label is not available on this site.
03/20/2008	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/10/2007	SUPPL-5	Labeling		Label is not available on this site.
03/16/2007	SUPPL-2	Labeling		Label is not available on this site.
03/16/2007	SUPPL-1	Manufacturing (CMC)-New Strength		Label is not available on this site.

Therapeutic Equivalents for ANDA 077094

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