Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077053
Company: HERITAGE PHARMA AVET

Products on ANDA 077053

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077053

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
05/08/2023	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
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.