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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077224
Company: ZYDUS PHARMS USA

Products on ANDA 077224

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077224

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2005	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
04/13/2021	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/13/2021	SUPPL-21	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/13/2021	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/11/2016	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
03/02/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
03/02/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/06/2011	SUPPL-11	REMS-Modified		Label is not available on this site.
03/18/2011	SUPPL-10	REMS-Proposal		Label is not available on this site.
03/18/2011	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/11/2008	SUPPL-7	Labeling		Label is not available on this site.
02/14/2008	SUPPL-6	Labeling		Label is not available on this site.
02/27/2007	SUPPL-5	Labeling		Label is not available on this site.
01/03/2007	SUPPL-4	Labeling		Label is not available on this site.
11/20/2006	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077224

RIBAVIRIN

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RIBAVIRIN	RIBAVIRIN	200MG	CAPSULE;ORAL	Prescription	No	AB	079117	AUROBINDO PHARMA
RIBAVIRIN	RIBAVIRIN	200MG	CAPSULE;ORAL	Prescription	No	AB	077224	ZYDUS PHARMS USA

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