Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079117
Company: AUROBINDO PHARMA

Products on ANDA 079117

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079117

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/2009	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
03/22/2023	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/14/2021	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/14/2021	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/14/2021	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/11/2016	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
05/19/2014	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
05/19/2014	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/19/2014	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/16/2011	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified		Label is not available on this site.
04/02/2010	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 079117

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