Last Updated: September 24, 2026

Details for New Drug Application (NDA): 204094

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NDA 204094 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, Aurobindo Pharma, Orbion Pharms, Sciegen Pharms, Square Pharms, Accord Hlthcare, Aiping Pharm Inc, Ajanta Pharma Ltd, Alkem Labs Ltd, Hetero Labs Ltd V, Lupin, Macleods Pharms, Prinston Inc, Rising, Sunshine, Teva Pharms Usa, Torrent, Unichem, and Zydus Pharms, and is included in thirty-seven NDAs. It is available from forty-seven suppliers. Additional details are available on the ARIPIPRAZOLE profile page.

The generic ingredient in ARIPIPRAZOLE is aripiprazole. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

Summary for 204094

Tradename:	ARIPIPRAZOLE
Applicant:	Apotex
Ingredient:	aripiprazole
Patents:	0

Pharmacology for NDA: 204094

Medical Subject Heading (MeSH) Categories for 204094

Antipsychotic Agents

Suppliers and Packaging for NDA: 204094

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARIPIPRAZOLE	aripiprazole	SOLUTION;ORAL	204094	ANDA	Apotex Corp.	60505-0404	60505-0404-5	1 BOTTLE in 1 CARTON (60505-0404-5) / 150 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1MG/ML
Approval Date:	Sep 30, 2015	TE:	AA	RLD:	No

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