Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076192
Company: CHARTWELL RX

• Exclusivity Letter

Products on ANDA 076192

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076192

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/2004	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76192lbl_Ribavarin_Sandoz.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76192ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/11/2016	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/08/2014	SUPPL-18	Labeling-Patient Package Insert		Label is not available on this site.
07/08/2014	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
07/08/2014	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
08/01/2011	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert, REMS-Proposal		Label is not available on this site.
07/21/2008	SUPPL-12	Labeling		Label is not available on this site.
01/04/2008	SUPPL-11	Labeling		Label is not available on this site.
03/28/2006	SUPPL-3	Labeling		Label is not available on this site.
09/15/2004	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 076192

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/06/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76192lbl_Ribavarin_Sandoz.pdf