Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/06/2009 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022192lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022192s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022192s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022192s000TOC.cfm
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022192s018s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022192Orig1s018,s021ltr.pdf
01/06/2017 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/23/2017 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022192s018s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022192Orig1s018,s021ltr.pdf
01/05/2016 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022192s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022192Orig1s017ltr.pdf
03/29/2016 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/26/2016 SUPPL-15 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022192s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022192Orig1s015ltr.pdf
03/30/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/21/2014 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022192s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022192Orig1s013ltr.pdf
07/19/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/30/2013 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/12/2013 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/27/2012 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022192s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022192s009ltr.pdf
01/31/2013 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022192s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022192Orig1s007ltr.pdf
09/07/2011 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022192s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022192s005,s006ltr.pdf
09/07/2011 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022192s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022192s005,s006ltr.pdf
03/21/2011 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022192s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022192s004ltr.pdf
12/01/2010 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022192s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022192s002ltr.pdf
08/24/2010 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022192s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022192s001ltr.pdf
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

FANAPT

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FANAPT ILOPERIDONE 1MG TABLET;ORAL Prescription Yes AB 022192 VANDA PHARMS INC
ILOPERIDONE ILOPERIDONE 1MG TABLET;ORAL Prescription No AB 207231 INVENTIA HLTHCARE

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FANAPT ILOPERIDONE 2MG TABLET;ORAL Prescription Yes AB 022192 VANDA PHARMS INC
ILOPERIDONE ILOPERIDONE 2MG TABLET;ORAL Prescription No AB 207231 INVENTIA HLTHCARE

TABLET;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FANAPT ILOPERIDONE 4MG TABLET;ORAL Prescription Yes AB 022192 VANDA PHARMS INC
ILOPERIDONE ILOPERIDONE 4MG TABLET;ORAL Prescription No AB 207231 INVENTIA HLTHCARE

TABLET;ORAL; 6MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FANAPT ILOPERIDONE 6MG TABLET;ORAL Prescription Yes AB 022192 VANDA PHARMS INC
ILOPERIDONE ILOPERIDONE 6MG TABLET;ORAL Prescription No AB 207231 INVENTIA HLTHCARE

TABLET;ORAL; 8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FANAPT ILOPERIDONE 8MG TABLET;ORAL Prescription Yes AB 022192 VANDA PHARMS INC
ILOPERIDONE ILOPERIDONE 8MG TABLET;ORAL Prescription No AB 207231 INVENTIA HLTHCARE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FANAPT ILOPERIDONE 10MG TABLET;ORAL Prescription Yes AB 022192 VANDA PHARMS INC
ILOPERIDONE ILOPERIDONE 10MG TABLET;ORAL Prescription No AB 207231 INVENTIA HLTHCARE

TABLET;ORAL; 12MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FANAPT ILOPERIDONE 12MG TABLET;ORAL Prescription Yes AB 022192 VANDA PHARMS INC
ILOPERIDONE ILOPERIDONE 12MG TABLET;ORAL Prescription No AB 207231 INVENTIA HLTHCARE

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