Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 207202
Company: OTSUKA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABILIFY MYCITE KIT ARIPIPRAZOLE 2MG TABLET;ORAL Prescription None Yes No
ABILIFY MYCITE KIT ARIPIPRAZOLE 5MG TABLET;ORAL Prescription None Yes Yes
ABILIFY MYCITE KIT ARIPIPRAZOLE 10MG TABLET;ORAL Prescription None Yes No
ABILIFY MYCITE KIT ARIPIPRAZOLE 15MG TABLET;ORAL Prescription None Yes No
ABILIFY MYCITE KIT ARIPIPRAZOLE 20MG TABLET;ORAL Prescription None Yes No
ABILIFY MYCITE KIT ARIPIPRAZOLE 30MG 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
11/13/2017 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207202lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207202Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207202Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/05/2020 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021436Orig1s044, s045; 202971Orig1s013; 207202Orig1s002, s004; 021713Orig1s035, s036; 021729Orig1s027, s028; 021866Orig1s029, s030ltr.pdf
12/19/2020 SUPPL-3 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s003lbl.pdf
02/05/2020 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021436Orig1s044, s045; 202971Orig1s013; 207202Orig1s002, s004; 021713Orig1s035, s036; 021729Orig1s027, s028; 021866Orig1s029, s030ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/19/2020 SUPPL-3 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s003lbl.pdf
02/05/2020 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s002s004lbl.pdf
02/05/2020 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s002s004lbl.pdf
11/13/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207202lbl.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