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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 202547

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NDA 202547 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 202547

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

Pharmacology for NDA: 202547

Medical Subject Heading (MeSH) Categories for 202547

Antipsychotic Agents

Suppliers and Packaging for NDA: 202547

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARIPIPRAZOLE	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	202547	ANDA	Bionpharma Inc.	69452-338	69452-338-13	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (69452-338-13)
ARIPIPRAZOLE	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	202547	ANDA	Bionpharma Inc.	69452-339	69452-339-13	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (69452-339-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	10MG
Approval Date:	Dec 11, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	15MG
Approval Date:	Dec 11, 2017	TE:	AB	RLD:	No

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