Application 217006

Type
NDA
Sponsor
OTSUKA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABILIFY ASIMTUFIIARIPIPRAZOLESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR720MG/2.4ML (300MG/ML)YesNo
002ABILIFY ASIMTUFIIARIPIPRAZOLESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR960MG/3.2ML (300MG/ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85204SUPPL 2026-03-02
81893SUPPL 2025-04-09
81143SUPPL 2025-02-07
81018SUPPL 2025-02-05
81017SUPPL 2025-02-05
77509ORIG 2024-02-16
74132ORIG 2023-05-01
74119ORIG 2023-04-28