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Last Updated: July 13, 2020

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Details for New Drug Application (NDA): 209830

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NDA 209830 describes ARISTADA INITIO KIT, which is a drug marketed by Alkermes Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ARISTADA INITIO KIT profile page.

The generic ingredient in ARISTADA INITIO KIT is aripiprazole lauroxil. There are forty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aripiprazole lauroxil profile page.
Summary for 209830
Applicant:Alkermes Inc
Ingredient:aripiprazole lauroxil
Suppliers and Packaging for NDA: 209830
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARISTADA INITIO KIT aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 209830 NDA Alkermes, Inc. 65757-500 65757-500-03 1 SYRINGE in 1 CARTON (65757-500-03) > 2.4 mL in 1 SYRINGE

Profile for product number 001

Approval Date:Jun 29, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 5, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Sep 8, 2035Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 24, 2030Product Flag?Substance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Harvard Business School
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