Details for New Drug Application (NDA): 216150

NDA 216150 describes ARIPIPRAZOLE, which is a drug marketed by Amneal Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Lannett Co Inc, Rubicon, Vistapharm, Alembic, Orbion Pharms, Sciegen Pharms Inc, Square Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Aurobindo Pharma, Breckenridge, Hetero Labs Ltd V, Lupin, Macleods Pharms Ltd, Norvium Bioscience, Prinston Inc, Sunshine, Teva Pharms Usa, Torrent, Unichem, and Zydus Pharms, and is included in thirty-four NDAs. It is available from forty-five 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-seven suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

Summary for 216150

Tradename:	ARIPIPRAZOLE
Applicant:	Hetero Labs Ltd Iii
Ingredient:	aripiprazole
Patents:	0

Pharmacology for NDA: 216150

Medical Subject Heading (MeSH) Categories for 216150

Antipsychotic Agents

Suppliers and Packaging for NDA: 216150

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARIPIPRAZOLE	aripiprazole	SOLUTION;ORAL	216150	ANDA	Camber Pharmaceuticals, Inc.	31722-684	31722-684-15	1 BOTTLE in 1 CARTON (31722-684-15) / 150 mL in 1 BOTTLE
ARIPIPRAZOLE	aripiprazole	SOLUTION;ORAL	216150	ANDA	NorthStar RxLLC	72603-445	72603-445-01	1 BOTTLE in 1 CARTON (72603-445-01) / 150 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1MG/ML
Approval Date:	Nov 1, 2023	TE:	AA	RLD:	No

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