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Details for New Drug Application (NDA): 205422

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NDA 205422 describes REXULTI, which is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the REXULTI profile page.

The generic ingredient in REXULTI is brexpiprazole. One supplier is listed for this compound. Additional details are available on the brexpiprazole profile page.

Summary for NDA: 205422

Otsuka Pharm Co Ltd

Pharmacology for NDA: 205422

Suppliers and Packaging for NDA: 205422

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 205422 NDA Otsuka America Pharmaceutical, Inc. 59148-035 59148-035-13 30 TABLET in 1 BOTTLE (59148-035-13)
TABLET;ORAL 205422 NDA Otsuka America Pharmaceutical, Inc. 59148-036 59148-036-13 30 TABLET in 1 BOTTLE (59148-036-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jul 10, 2015TE:RLD:No
Regulatory Exclusivity Expiration:Sep 23, 2019
Regulatory Exclusivity Use:
Patent:7,888,362Patent Expiration:Feb 23, 2027Product Flag?Substance Flag?YDelist Request?
Patent:8,349,840Patent Expiration:Apr 12, 2026Product Flag?YSubstance Flag?Delist Request?

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