Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022192
Company: VANDA PHARMS INC

• Other Important Information from FDA

• Summary Review

Products on NDA 22192

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FANAPT	ILOPERIDONE	1MG	TABLET;ORAL	Prescription	AB	Yes	Yes
FANAPT	ILOPERIDONE	2MG	TABLET;ORAL	Prescription	AB	Yes	No
FANAPT	ILOPERIDONE	4MG	TABLET;ORAL	Prescription	AB	Yes	No
FANAPT	ILOPERIDONE	6MG	TABLET;ORAL	Prescription	AB	Yes	No
FANAPT	ILOPERIDONE	8MG	TABLET;ORAL	Prescription	AB	Yes	No
FANAPT	ILOPERIDONE	10MG	TABLET;ORAL	Prescription	AB	Yes	No
FANAPT	ILOPERIDONE	12MG	TABLET;ORAL	Prescription	AB	Yes	No

Labels for NDA 022192

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2024	SUPPL-23	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022192s023lbl.pdf
02/23/2017	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022192s018s021lbl.pdf
02/23/2017	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022192s018s021lbl.pdf
05/26/2016	SUPPL-15	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022192s015lbl.pdf
01/05/2016	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022192s017lbl.pdf
04/21/2014	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022192s013lbl.pdf
01/31/2013	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022192s007lbl.pdf
01/27/2012	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022192s009lbl.pdf
09/07/2011	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022192s005s006lbl.pdf
09/07/2011	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022192s005s006lbl.pdf
03/21/2011	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022192s004lbl.pdf
12/01/2010	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022192s002lbl.pdf
08/24/2010	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022192s001lbl.pdf
05/06/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022192lbl.pdf