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FDA NDA · NDA207202

ABILIFY MYCITE KIT

Sponsor: OTSUKA

APPLICATION
NDA207202
TYPE
NDA
ORIGINAL APPROVAL
2017-11-13
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ABILIFY MYCITE KIT · ReferenceDiscontinued
ARIPIPRAZOLE 2MG · TABLET · ORAL
ABILIFY MYCITE KIT · ReferenceDiscontinued
ARIPIPRAZOLE 30MG · TABLET · ORAL
ABILIFY MYCITE KIT · ReferenceDiscontinued
ARIPIPRAZOLE 15MG · TABLET · ORAL
ABILIFY MYCITE KIT · ReferenceDiscontinued
ARIPIPRAZOLE 5MG · TABLET · ORAL
ABILIFY MYCITE KIT · ReferenceDiscontinued
ARIPIPRAZOLE 20MG · TABLET · ORAL
ABILIFY MYCITE KIT · ReferenceDiscontinued
ARIPIPRAZOLE 10MG · TABLET · ORAL

Approval history

2025-01-22Labeling · Supplement 9 · standard — Label ↗AP
2025-01-22Labeling · Supplement 8 · standardAP
2022-11-30Labeling · Supplement 6 · standard — Letter ↗AP
2020-12-19Manufacturing (CMC) · Supplement 3 · standard — Label ↗AP
2020-02-05Labeling · Supplement 4 · 901 required — Letter ↗AP
2020-02-05Labeling · Supplement 2 · standard — Letter ↗AP
2017-11-13Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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