Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021999
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INVEGA PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
INVEGA PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
INVEGA PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
INVEGA PALIPERIDONE 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
INVEGA PALIPERIDONE 1.5MG TABLET, EXTENDED RELEASE;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
12/19/2006 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021999lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021999s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021999s000_TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/25/2019 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021999s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021999Orig1s036,022264Orig1s029,207946Orig1s008Ltr.pdf
07/27/2018 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021999s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021999Orig1s035,022264Orig1s027,207946Orig1s006ltr.pdf
08/11/2017 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021999s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021999Orig1s034ltr.pdf
02/23/2017 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021999s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021999Orig1s032,022264Orig1s024,207946Orig1s003ltr.pdf
03/01/2016 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021999s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf
04/29/2014 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021999s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021999Orig1s029,022264Orig1s010ltr.pdf
06/17/2013 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/06/2011 SUPPL-24 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s020s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021999s020,s024ltr.pdf
12/01/2010 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021999s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021999s023ltr.pdf
04/06/2011 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s020s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021999s020,s024ltr.pdf
03/03/2010 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021999s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021999s018ltr.pdf
02/16/2011 SUPPL-17 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021999s017ltr.pdf
07/19/2009 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021999s015ltr.pdf
07/31/2009 SUPPL-14 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021999s013,s014ltr.pdf
07/31/2009 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021999s013,s014ltr.pdf
10/30/2009 SUPPL-11 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s011lbl.pdf
08/14/2008 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s010ltr.pdf
08/26/2008 SUPPL-8 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s005s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s005, s008ltr.pdf
05/16/2008 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s007ltr.pdf
09/04/2008 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s006ltr.pdf
08/26/2008 SUPPL-5 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s005s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s005, s008ltr.pdf
12/22/2009 SUPPL-4 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021999Orig1s004.pdf
04/27/2007 SUPPL-3 Labeling

Label is not available on this site.

12/21/2007 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021999s001,s002ltr.pdf
12/21/2007 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021999s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021999s001,s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/25/2019 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021999s036lbl.pdf
07/27/2018 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021999s035lbl.pdf
08/11/2017 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021999s034lbl.pdf
02/23/2017 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021999s032lbl.pdf
03/01/2016 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021999s030lbl.pdf
04/29/2014 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021999s029lbl.pdf
04/06/2011 SUPPL-24 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s020s024lbl.pdf
04/06/2011 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s020s024lbl.pdf
02/16/2011 SUPPL-17 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s017lbl.pdf
12/01/2010 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021999s023lbl.pdf
03/03/2010 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021999s018lbl.pdf
10/30/2009 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s011lbl.pdf
07/31/2009 SUPPL-14 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s013s014lbl.pdf
07/31/2009 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s013s014lbl.pdf
07/19/2009 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s015lbl.pdf
09/04/2008 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s006lbl.pdf
08/26/2008 SUPPL-8 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s005s008lbl.pdf
08/26/2008 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s005s008lbl.pdf
08/26/2008 SUPPL-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s005s008lbl.pdf
08/14/2008 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s010lbl.pdf
12/21/2007 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021999s001lbl.pdf
12/19/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021999lbl.pdf

INVEGA

TABLET, EXTENDED RELEASE;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INVEGA PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021999 JANSSEN PHARMS
PALIPERIDONE PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202645 ACTAVIS LABS FL INC
PALIPERIDONE PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204707 AMNEAL PHARMS
PALIPERIDONE PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204452 INVENTIA
PALIPERIDONE PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203802 MYLAN
PALIPERIDONE PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205618 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 6MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INVEGA PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021999 JANSSEN PHARMS
PALIPERIDONE PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202645 ACTAVIS LABS FL INC
PALIPERIDONE PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204707 AMNEAL PHARMS
PALIPERIDONE PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204452 INVENTIA
PALIPERIDONE PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203802 MYLAN
PALIPERIDONE PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205618 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 9MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INVEGA PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021999 JANSSEN PHARMS
PALIPERIDONE PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202645 ACTAVIS LABS FL INC
PALIPERIDONE PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204707 AMNEAL PHARMS
PALIPERIDONE PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204452 INVENTIA
PALIPERIDONE PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203802 MYLAN
PALIPERIDONE PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205618 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 1.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INVEGA PALIPERIDONE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021999 JANSSEN PHARMS
PALIPERIDONE PALIPERIDONE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202645 ACTAVIS LABS FL INC
PALIPERIDONE PALIPERIDONE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204707 AMNEAL PHARMS
PALIPERIDONE PALIPERIDONE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204452 INVENTIA
PALIPERIDONE PALIPERIDONE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203802 MYLAN
PALIPERIDONE PALIPERIDONE 1.5mg TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205618 SUN PHARM

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