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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 207625


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NDA 207625 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 207625
Pharmacology for NDA: 207625
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 207625
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207625 ANDA Aurobindo Pharma Limited 65862-943 65862-943-24 2 POUCH in 1 CARTON (65862-943-24) / 12 VIAL, SINGLE-DOSE in 1 POUCH (65862-943-12) / 3 mL in 1 VIAL, SINGLE-DOSE
LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207625 ANDA Aurobindo Pharma Limited 65862-944 65862-944-24 2 POUCH in 1 CARTON (65862-944-24) / 12 VIAL, SINGLE-DOSE in 1 POUCH (65862-944-12) / 3 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.0103% BASE
Approval Date:Dec 30, 2016TE:ANRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Dec 30, 2016TE:ANRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Dec 30, 2016TE:ANRLD:No

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