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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 201519

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NDA 201519 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-seven 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. Fifty suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

Summary for 201519

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

Pharmacology for NDA: 201519

Medical Subject Heading (MeSH) Categories for 201519

Antipsychotic Agents

Suppliers and Packaging for NDA: 201519

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	201519	ANDA	Major Pharmaceuticals	0904-6656	0904-6656-40	500 TABLET in 1 BOTTLE (0904-6656-40)
ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	201519	ANDA	Torrent Pharmaceuticals Limited	13668-216	13668-216-01	100 TABLET in 1 BOTTLE (13668-216-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Apr 28, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Apr 28, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Apr 28, 2015	TE:	AB	RLD:	No

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