Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022192
Company: VANDA PHARMS INC
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 |
---|---|---|---|---|---|
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 |