Last Updated: May 11, 2026

Details for New Drug Application (NDA): 202683

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NDA 202683 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-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 202683

Tradename:	ARIPIPRAZOLE
Applicant:	Orbion Pharms
Ingredient:	aripiprazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 202683

Antipsychotic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	May 23, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 23, 2017	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 23, 2017	TE:	AB	RLD:	No

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