Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021713
Company: OTSUKA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABILIFY ARIPIPRAZOLE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;ORAL Discontinued None Yes No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
12/10/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021713lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021713ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021713s000_AbilifyTOC2.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2017 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021436s042,021713s033,021729s025,021866s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021436Orig1s042,021713Orig2s033,021729Orig1s025,021866Orig1s027,202971Orig1s011ltr.pdf
08/18/2016 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021436s041,021713s032,021729s024,021866s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s041,021713Orig1s032,021729Orig1s024,021866Orig1s026,202971Orig1s009ltr.pdf
01/15/2016 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/21436s04021713s03121729s02321866s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s040,021713Orig1s031,021729Orig1s023,021866Orig1s025,0202971Orig1s008ltr.pdf
12/12/2014 SUPPL-30 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s038,021713s030,021729s022,021866s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s038,021713Orig1s030,021729Orig1s022,021866Orig1s023ltr.pdf
07/30/2013 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021436s037,021713s029,021729s021,021866s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021436Orig1s037,021713Orig1s029,021729Orig1s021,021866Orig1s022ltr.pdf
06/09/2014 SUPPL-28 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s036,021866s021,021729s020,021713s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s036,021713Orig1s028,021729Orig1s020,021866Orig1s021ltr.pdf
02/22/2012 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021436s034,021713s025,021729s018,021866s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021436s034,021866s020,021713s025,021729s018ltr.pdf
03/02/2011 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s032,021866s019,021713s024,021729s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s032,21866s019,21713s024,21729s017ltr.pdf
12/01/2010 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s031,021866s018,021713s023,021729s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s031,021866s018,021713s023,021729s016ltr.pdf
11/30/2010 SUPPL-22 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s030,021866s017,021713s022,021729s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s030,021866s017,021713s022,021729s015ltr.pdf
02/16/2011 SUPPL-21 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s029,021713s021,021729s014,021866s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s029,021729s014,021713s021,021866s016ltr.pdf
07/19/2009 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021436s028,021713s020,021729s013,021866s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021436s028,021713s020,021729s013,021866s014ltr.pdf
08/14/2008 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s026,021729s012,021713s019,021866s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s026,021713s019,021729s012,021866s013ltr.pdf
03/06/2008 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s023,021713s018,021729s010,021866s010ltr.pdf
05/06/2008 SUPPL-17 Labeling Letter (PDF)
Review (PDF)
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021713se1-015,021713s017,021729se2-006,021729se1-007.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021713Orig1s014_s015_s017.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,21713s14s15s017SUMR.pdf
02/27/2008 SUPPL-16 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s21,021713s16,021729s8,021866s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s021, 021713s016, 021729s008, 021866s008ltr.pdf
05/06/2008 SUPPL-15 Efficacy-New Indication Letter (PDF)
Review (PDF)
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021713se1-015,021713s017,021729se2-006,021729se1-007.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021713Orig1s014_s015_s017.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,21713s14s15s017SUMR.pdf
05/06/2008 SUPPL-14 Efficacy-New Dosing Regimen Letter (PDF)
Review (PDF)
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436se2-019,021436se1-020,021436s022,021713se2-014.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021713Orig1s014_s015_s017.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,21713s14s15s017SUMR.pdf
11/16/2007 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s018,021713s013,21729s005,021866s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s018, 021866s005, 021729s005, 021713s013ltr.pdf
10/29/2007 SUPPL-12 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s017,021713s012,21729s004,021866s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s017, 021713s012, 021729s004, 021866s004ltr.pdf
09/25/2007 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021866s2s3,021729s2,021713s10,021436s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s016,021713s010,021729s002,021866s3s2ltr.pdf
09/18/2006 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s014,021713s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s014, 021713s009ltr.pdf
10/20/2006 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s013,021713s008,021729s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s013, 021713s008, 021729s001ltr.pdf
02/16/2006 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s010,021713s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s010,021713s006ltr.pdf
06/21/2005 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021713s004,021436s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021713s004,021436s007ltr.pdf
03/01/2005 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21436s005,008,21713s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21436s005,008,21713s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/23/2017 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021436s042,021713s033,021729s025,021866s027lbl.pdf
08/18/2016 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021436s041,021713s032,021729s024,021866s026lbl.pdf
01/15/2016 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/21436s04021713s03121729s02321866s025lbl.pdf
12/12/2014 SUPPL-30 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s038,021713s030,021729s022,021866s023lbl.pdf
06/09/2014 SUPPL-28 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s036,021866s021,021729s020,021713s028lbl.pdf
07/30/2013 SUPPL-29 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021436s037,021713s029,021729s021,021866s022lbl.pdf
07/30/2013 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021436s037,021713s029,021729s021,021866s022lbl.pdf
02/22/2012 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021436s034,021713s025,021729s018,021866s020lbl.pdf
03/02/2011 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s032,021866s019,021713s024,021729s017lbl.pdf
02/16/2011 SUPPL-21 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s029,021713s021,021729s014,021866s016lbl.pdf
12/01/2010 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s031,021866s018,021713s023,021729s016lbl.pdf
11/30/2010 SUPPL-22 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s030,021866s017,021713s022,021729s015lbl.pdf
07/19/2009 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021436s028,021713s020,021729s013,021866s014lbl.pdf
08/14/2008 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s026,021729s012,021713s019,021866s013lbl.pdf
02/27/2008 SUPPL-16 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s21,021713s16,021729s8,021866s8lbl.pdf
11/16/2007 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s018,021713s013,21729s005,021866s005lbl.pdf
10/29/2007 SUPPL-12 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s017,021713s012,21729s004,021866s004lbl.pdf
09/25/2007 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021866s2s3,021729s2,021713s10,021436s16lbl.pdf
10/20/2006 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s013,021713s008,021729s001lbl.pdf
09/18/2006 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s014,021713s009lbl.pdf
02/16/2006 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s010,021713s006lbl.pdf
06/21/2005 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021713s004,021436s007lbl.pdf
03/01/2005 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21436s005,008,21713s003lbl.pdf
12/10/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021713lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English