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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205422
Company: OTSUKA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REXULTI BREXPIPRAZOLE 0.25MG TABLET;ORAL Prescription AB Yes No
REXULTI BREXPIPRAZOLE 0.5MG TABLET;ORAL Prescription AB Yes No
REXULTI BREXPIPRAZOLE 1MG TABLET;ORAL Prescription AB Yes No
REXULTI BREXPIPRAZOLE 2MG TABLET;ORAL Prescription AB Yes Yes
REXULTI BREXPIPRAZOLE 3MG TABLET;ORAL Prescription AB Yes No
REXULTI BREXPIPRAZOLE 4MG 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
07/10/2015 ORIG-2 Approval Efficacy STANDARD Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205422Orig1Orig2s000lbl.pdf
07/10/2015 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205422Orig1Orig2s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205422Orig1Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205422s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/06/2022 SUPPL-8 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205422Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205422Orig1s008ltr.pdf
12/27/2021 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205422s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205422Orig1s007ltr.pdf
06/17/2020 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205422s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205422Orig1s005ltr.pdf
02/09/2018 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205422s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205422Orig1s003ltr.pdf
02/23/2017 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205422s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205422Orig1s002ltr.pdf
09/23/2016 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205422s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205422Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/06/2022 SUPPL-8 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205422Orig1s008lbl.pdf
12/27/2021 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205422s007lbl.pdf
06/17/2020 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205422s005lbl.pdf
02/09/2018 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205422s003lbl.pdf
02/09/2018 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205422s003lbl.pdf
02/23/2017 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205422s002lbl.pdf
09/23/2016 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205422s001lbl.pdf
07/10/2015 ORIG-2 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205422Orig1Orig2s000lbl.pdf
07/10/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205422Orig1Orig2s000lbl.pdf

REXULTI

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREXPIPRAZOLE BREXPIPRAZOLE 0.25MG TABLET;ORAL Prescription No AB 213570 SANDOZ INC
BREXPIPRAZOLE BREXPIPRAZOLE 0.25MG TABLET;ORAL Prescription No AB 213692 TEVA PHARMS USA INC
REXULTI BREXPIPRAZOLE 0.25MG TABLET;ORAL Prescription Yes AB 205422 OTSUKA

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREXPIPRAZOLE BREXPIPRAZOLE 0.5MG TABLET;ORAL Prescription No AB 213570 SANDOZ INC
BREXPIPRAZOLE BREXPIPRAZOLE 0.5MG TABLET;ORAL Prescription No AB 213692 TEVA PHARMS USA INC
REXULTI BREXPIPRAZOLE 0.5MG TABLET;ORAL Prescription Yes AB 205422 OTSUKA

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREXPIPRAZOLE BREXPIPRAZOLE 1MG TABLET;ORAL Prescription No AB 213570 SANDOZ INC
BREXPIPRAZOLE BREXPIPRAZOLE 1MG TABLET;ORAL Prescription No AB 213692 TEVA PHARMS USA INC
REXULTI BREXPIPRAZOLE 1MG TABLET;ORAL Prescription Yes AB 205422 OTSUKA

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREXPIPRAZOLE BREXPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 213570 SANDOZ INC
BREXPIPRAZOLE BREXPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 213692 TEVA PHARMS USA INC
REXULTI BREXPIPRAZOLE 2MG TABLET;ORAL Prescription Yes AB 205422 OTSUKA

TABLET;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREXPIPRAZOLE BREXPIPRAZOLE 3MG TABLET;ORAL Prescription No AB 213570 SANDOZ INC
BREXPIPRAZOLE BREXPIPRAZOLE 3MG TABLET;ORAL Prescription No AB 213692 TEVA PHARMS USA INC
REXULTI BREXPIPRAZOLE 3MG TABLET;ORAL Prescription Yes AB 205422 OTSUKA

TABLET;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREXPIPRAZOLE BREXPIPRAZOLE 4MG TABLET;ORAL Prescription No AB 213570 SANDOZ INC
BREXPIPRAZOLE BREXPIPRAZOLE 4MG TABLET;ORAL Prescription No AB 213692 TEVA PHARMS USA INC
REXULTI BREXPIPRAZOLE 4MG TABLET;ORAL Prescription Yes AB 205422 OTSUKA
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