Home Applications 217006 Application 217006
Type NDA
Sponsor OTSUKA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ABILIFY ASIMTUFII ARIPIPRAZOLE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 720MG/2.4ML (300MG/ML) Yes No 002 ABILIFY ASIMTUFII ARIPIPRAZOLE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 960MG/3.2ML (300MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217006-001 ABILIFY ASIMTUFII ARIPIPRAZOLE 720MG/2.4ML (300MG/ML) SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR RLD 2023-04-27 N217006-002 ABILIFY ASIMTUFII ARIPIPRAZOLE 960MG/3.2ML (300MG/ML) SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR RLD, RS 2023-04-27
Orange Book patents# Current patent rows page 1 of 1 · 16 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217006-001 10517951 2033-04-23 U-3245 Drug product 2023-05-25 N217006-001 10517951 2033-04-23 U-814 Drug product 2023-05-25 N217006-001 11097007 2033-04-23 U-3245 Drug product 2023-05-25 N217006-001 11097007 2033-04-23 U-814 Drug product 2023-05-25 N217006-001 11638757 2033-04-23 U-3245 Drug product 2023-05-25 N217006-001 11638757 2033-04-23 U-814 Drug product 2023-05-25 N217006-001 12016927 2033-04-23 U-3245 Drug product 2024-07-24 N217006-001 12016927 2033-04-23 U-543 Drug product 2024-07-24 N217006-002 10517951 2033-04-23 U-3245 Drug product 2023-05-25 N217006-002 10517951 2033-04-23 U-814 Drug product 2023-05-25 N217006-002 11097007 2033-04-23 U-3245 Drug product 2023-05-25 N217006-002 11097007 2033-04-23 U-814 Drug product 2023-05-25 N217006-002 11638757 2033-04-23 U-3245 Drug product 2023-05-25 N217006-002 11638757 2033-04-23 U-814 Drug product 2023-05-25 N217006-002 12016927 2033-04-23 U-3245 Drug product 2024-07-24 N217006-002 12016927 2033-04-23 U-543 Drug product 2024-07-24
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N217006-001 ABILIFY ASIMTUFII 720MG/2.4ML (300MG/ML) SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR RLD 2023-04-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-002 ABILIFY ASIMTUFII 960MG/3.2ML (300MG/ML) SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR RLD, RS 2023-04-27 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N217006-001 10517951 2033-04-23 U-3245 Drug product 2023-05-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-001 10517951 2033-04-23 U-814 Drug product 2023-05-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-001 11097007 2033-04-23 U-3245 Drug product 2023-05-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-001 11097007 2033-04-23 U-814 Drug product 2023-05-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-001 11638757 2033-04-23 U-3245 Drug product 2023-05-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-001 11638757 2033-04-23 U-814 Drug product 2023-05-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-001 12016927 2033-04-23 U-3245 Drug product 2024-07-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-001 12016927 2033-04-23 U-543 Drug product 2024-07-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-002 10517951 2033-04-23 U-814 Drug product 2023-05-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-002 10517951 2033-04-23 U-3245 Drug product 2023-05-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-002 11097007 2033-04-23 U-814 Drug product 2023-05-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-002 11097007 2033-04-23 U-3245 Drug product 2023-05-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-002 11638757 2033-04-23 U-814 Drug product 2023-05-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-002 11638757 2033-04-23 U-3245 Drug product 2023-05-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-002 12016927 2033-04-23 U-543 Drug product 2024-07-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N217006-002 12016927 2033-04-23 U-3245 Drug product 2024-07-24 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Documents# Document, Submission type, Date table Document Submission type Date 85204 SUPPL 2026-03-02 81893 SUPPL 2025-04-09 81143 SUPPL 2025-02-07 81018 SUPPL 2025-02-05 81017 SUPPL 2025-02-05 77509 ORIG 2024-02-16 74132 ORIG 2023-05-01 74119 ORIG 2023-04-28