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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022192
Company: VANDA PHARMS INC
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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
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