Last Updated: August 2, 2026

Details for New Drug Application (NDA): 215217

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NDA 215217 describes LEVALBUTEROL HYDROCHLORIDE, which is a drug marketed by Cipla, Impax Labs Inc, Luoxin Aurovitas, Mankind Pharma, Mylan Speciality Lp, Nephron, Pharmobedient, Ritedose Corp, Sun Pharm, Teva Parenteral, and Teva Pharms Usa, and is included in twelve NDAs. It is available from twelve suppliers. Additional details are available on the LEVALBUTEROL HYDROCHLORIDE profile page.

The generic ingredient in LEVALBUTEROL HYDROCHLORIDE is levalbuterol hydrochloride. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the levalbuterol hydrochloride profile page.

Summary for 215217

Tradename:	LEVALBUTEROL HYDROCHLORIDE
Applicant:	Nephron
Ingredient:	levalbuterol hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.021% BASE
Approval Date:	May 26, 2026	TE:	AN	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.042% BASE
Approval Date:	May 26, 2026	TE:	AN	RLD:	No

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