Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 205422
Company: OTSUKA PHARM CO LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REXULTI BREXPIPRAZOLE 0.25MG TABLET;ORAL Prescription None Yes No
REXULTI BREXPIPRAZOLE 0.5MG TABLET;ORAL Prescription None Yes No
REXULTI BREXPIPRAZOLE 1MG TABLET;ORAL Prescription None Yes No
REXULTI BREXPIPRAZOLE 2MG TABLET;ORAL Prescription None Yes Yes
REXULTI BREXPIPRAZOLE 3MG TABLET;ORAL Prescription None Yes No
REXULTI BREXPIPRAZOLE 4MG TABLET;ORAL Prescription 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
07/10/2015 ORIG-2 Approval Efficacy STANDARD

Label is not available on this site.

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/2015/205422s000lbl.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
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
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-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205422s000lbl.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