Last Updated: July 25, 2026

Details for New Drug Application (NDA): 216608

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NDA 216608 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 Ltd, 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 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 216608

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

Medical Subject Heading (MeSH) Categories for 216608

Antipsychotic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR			Strength	300MG/VIAL
Approval Date:	Dec 3, 2024	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR			Strength	400MG/VIAL
Approval Date:	Dec 3, 2024	TE:		RLD:	No

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