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Details for New Drug Application (NDA): 202971

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NDA 202971 describes ABILIFY MAINTENA KIT, which is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the ABILIFY MAINTENA KIT profile page.

The generic ingredient in ABILIFY MAINTENA KIT is aripiprazole. There are forty-two drug master file entries for this compound. Thirty-six suppliers are listed for this compound. There are sixteen tentative approvals for this compound. Additional details are available on the aripiprazole profile page.

Summary for NDA: 202971

Tradename:
ABILIFY MAINTENA KIT
Applicant:
Otsuka Pharm Co Ltd
Ingredient:
aripiprazole
Patents:9
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 202971

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971 NDA Otsuka America Pharmaceutical, Inc. 59148-018 59148-018-71 1 KIT in 1 CARTON (59148-018-71) * 1.5 mL in 1 VIAL, SINGLE-USE * 5 mL in 1 VIAL, SINGLE-USE
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971 NDA Otsuka America Pharmaceutical, Inc. 59148-019 59148-019-71 1 KIT in 1 CARTON (59148-019-71) * 1.9 mL in 1 VIAL, SINGLE-USE * 5 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrength300MG/VIAL
Approval Date:Feb 28, 2013TE:RLD:No
Patent:7,807,680Patent Expiration:Oct 19, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:8,399,469Patent Expiration:Jun 29, 2025Product Flag?Substance Flag?YDelist Request?
Patent:8,722,679Patent Expiration:Oct 19, 2024Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 202971

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 20135,006,528*PED► subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-004Sep 29, 20145,006,528*PED► subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-001Feb 28, 20135,006,528*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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