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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 078171


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NDA 078171 describes LEVALBUTEROL HYDROCHLORIDE, which is a drug marketed by Cipla, Impax Labs Inc, Luoxin Aurovitas, Mylan Speciality Lp, Norvium Bioscience, Ritedose Corp, Sun Pharm, Teva Parenteral, and Teva Pharms Usa, and is included in ten NDAs. It is available from eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the levalbuterol hydrochloride profile page.
Summary for 078171
Tradename:LEVALBUTEROL HYDROCHLORIDE
Applicant:Cipla
Ingredient:levalbuterol hydrochloride
Patents:0
Pharmacology for NDA: 078171
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 078171
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 078171 ANDA Dr. Reddy?s Laboratories, Inc. 43598-409 43598-409-25 5 POUCH in 1 CARTON (43598-409-25) / 5 VIAL in 1 POUCH (43598-409-05) / 3 mL in 1 VIAL
LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 078171 ANDA Dr. Reddy?s Laboratories, Inc. 43598-410 43598-410-25 5 POUCH in 1 CARTON (43598-410-25) / 5 VIAL in 1 POUCH (43598-410-05) / 3 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.0103% BASE
Approval Date:Dec 13, 2013TE:ANRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Dec 13, 2013TE:ANRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Dec 13, 2013TE:ANRLD:No

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