Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 200603
Company: SUNOVION PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LATUDA LURASIDONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription AB Yes Yes
LATUDA LURASIDONE HYDROCHLORIDE 80MG TABLET;ORAL Prescription AB Yes No
LATUDA LURASIDONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription AB Yes No
LATUDA LURASIDONE HYDROCHLORIDE 120MG TABLET;ORAL Prescription AB Yes No
LATUDA LURASIDONE HYDROCHLORIDE 60MG 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
10/28/2010 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200603s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200603s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/25/2017 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200603Orig1s030ltr.pdf
03/05/2018 SUPPL-29 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200603s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200603Orig1s029ltr.pdf
02/23/2017 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200603Orig1s028ltr.pdf
01/27/2017 SUPPL-27 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s26s27lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200603Orig1s26,s27ltr.pdf
01/27/2017 SUPPL-26 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s26s27lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200603Orig1s26,s27ltr.pdf
12/20/2016 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/08/2016 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/29/2016 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/11/2017 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200603Orig1s021ltr.pdf
07/30/2015 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/05/2015 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/28/2014 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/03/2013 SUPPL-16 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603Org1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Org1s016ltr.pdf
07/12/2013 SUPPL-15 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s015lbl.pdf
05/21/2014 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/22/2013 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s009s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s009,s013ltr.pdf
06/13/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/28/2013 SUPPL-11 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603lbls10s11.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s010,s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200603Orig1s011.pdf
06/28/2013 SUPPL-10 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603lbls10s11.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s010,s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200603Orig1s010.pdf
01/22/2013 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s009s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s009,s013ltr.pdf
04/26/2012 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200603s005s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200603s005,s007ltr.pdf
12/07/2011 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200603s004s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200603s004,s006ltr.pdf
04/26/2012 SUPPL-5 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200603s005s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200603s005,s007ltr.pdf
12/07/2011 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200603s004s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200603s004,s006ltr.pdf
12/10/2010 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200603s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200603s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/05/2018 SUPPL-29 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200603s029lbl.pdf
09/25/2017 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s030lbl.pdf
02/23/2017 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s028lbl.pdf
01/27/2017 SUPPL-27 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s26s27lbl.pdf
01/27/2017 SUPPL-26 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s26s27lbl.pdf
01/11/2017 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s021lbl.pdf
09/03/2013 SUPPL-16 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603Org1s016lbl.pdf
07/12/2013 SUPPL-15 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s015lbl.pdf
06/28/2013 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603lbls10s11.pdf
06/28/2013 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603lbls10s11.pdf
01/22/2013 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s009s013lbl.pdf
01/22/2013 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s009s013lbl.pdf
04/26/2012 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200603s005s007lbl.pdf
04/26/2012 SUPPL-5 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200603s005s007lbl.pdf
12/07/2011 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200603s004s006lbl.pdf
12/07/2011 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200603s004s006lbl.pdf
12/10/2010 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200603s001lbl.pdf
10/28/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200603s000lbl.pdf

LATUDA

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LATUDA LURASIDONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription Yes AB 200603 SUNOVION PHARMS INC
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 208049 ACCORD HLTHCARE
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 208066 SUN PHARM
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 208060 TEVA PHARMS USA

TABLET;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LATUDA LURASIDONE HYDROCHLORIDE 80MG TABLET;ORAL Prescription Yes AB 200603 SUNOVION PHARMS INC
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 208049 ACCORD HLTHCARE
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 208066 SUN PHARM
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 208060 TEVA PHARMS USA

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LATUDA LURASIDONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription Yes AB 200603 SUNOVION PHARMS INC
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 208049 ACCORD HLTHCARE
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 208066 SUN PHARM
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 208060 TEVA PHARMS USA

TABLET;ORAL; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LATUDA LURASIDONE HYDROCHLORIDE 120MG TABLET;ORAL Prescription Yes AB 200603 SUNOVION PHARMS INC
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 208049 ACCORD HLTHCARE
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 208066 SUN PHARM
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 208060 TEVA PHARMS USA

TABLET;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LATUDA LURASIDONE HYDROCHLORIDE 60MG TABLET;ORAL Prescription Yes AB 200603 SUNOVION PHARMS INC
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 208049 ACCORD HLTHCARE
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 208066 SUN PHARM
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 208060 TEVA PHARMS USA

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