Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207202
Company: OTSUKA PHARM CO LTD
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/13/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207202lbl.pdf

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