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Last Updated: June 30, 2022

Details for New Drug Application (NDA): 207202


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NDA 207202 describes ABILIFY MYCITE KIT, which is a drug marketed by Otsuka and is included in one NDA. It is available from one supplier. There are thirty-two patents protecting this drug. Additional details are available on the ABILIFY MYCITE KIT profile page.

The generic ingredient in ABILIFY MYCITE KIT is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 207202
Tradename:ABILIFY MYCITE KIT
Applicant:Otsuka
Ingredient:aripiprazole
Patents:32
Formulation / Manufacturing:see details
Pharmacology for NDA: 207202
Medical Subject Heading (MeSH) Categories for 207202
Suppliers and Packaging for NDA: 207202
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202 NDA Otsuka America Pharmaceutical, Inc. 59148-029 59148-029-61 1 BOTTLE in 1 KIT (59148-029-61) > 30 TABLET WITH SENSOR in 1 BOTTLE (59148-029-13)
ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202 NDA Otsuka America Pharmaceutical, Inc. 59148-029 59148-029-72 1 BOTTLE in 1 KIT (59148-029-72) > 30 TABLET WITH SENSOR in 1 BOTTLE (59148-029-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Nov 13, 2017TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Jul 26, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Jun 13, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Jul 11, 2031Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 207202

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-004 Nov 13, 2017 See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-006 Nov 13, 2017 See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-001 Nov 13, 2017 See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-002 Nov 13, 2017 See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-002 Nov 13, 2017 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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