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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215595

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NDA 215595 describes ARIPIPRAZOLE, which is a drug marketed by Mylan, Amneal Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Lannett Co Inc, Quagen, Rubicon Research, Vistapharm Llc, Alembic, Orbion Pharms, Sciegen Pharms Inc, Square Pharms, Accord Hlthcare, Aiping Pharm Inc, Ajanta Pharma Ltd, Alkem Labs Ltd, Aurobindo Pharma, Hetero Labs Ltd V, Lupin, Macleods Pharms Ltd, Prinston Inc, Rising, Sunshine, Teva Pharms Usa, Torrent, Unichem, and Zydus Pharms, and is included in thirty-six NDAs. It is available from forty-six suppliers. Additional details are available on the ARIPIPRAZOLE profile page.

The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

Summary for 215595

Tradename:	ARIPIPRAZOLE
Applicant:	Chartwell Rx
Ingredient:	aripiprazole
Patents:	0

Pharmacology for NDA: 215595

Medical Subject Heading (MeSH) Categories for 215595

Antipsychotic Agents

Suppliers and Packaging for NDA: 215595

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARIPIPRAZOLE	aripiprazole	SOLUTION;ORAL	215595	ANDA	Chartwell RX, LLC	62135-904	62135-904-51	150 mL in 1 BOTTLE (62135-904-51)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1MG/ML
Approval Date:	Oct 25, 2022	TE:	AA	RLD:	No

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