FDA Approval for FANAPT issued to VANDA PHARMS INC
$VNDA
Biotechnology: Pharmaceutical Preparations
Health Care
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 |
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 |
|---|---|---|---|---|---|
| 04/02/2024 | SUPPL-23 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022192s023lbl.pdf | ||
| 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 |
|---|---|---|---|---|---|
| 04/02/2024 | SUPPL-23 | Efficacy | 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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |