You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

Details for New Drug Application (NDA): 090297


✉ Email this page to a colleague

« Back to Dashboard


NDA 090297 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 090297
Tradename:LEVALBUTEROL HYDROCHLORIDE
Applicant:Teva Pharms Usa
Ingredient:levalbuterol hydrochloride
Patents:0
Pharmacology for NDA: 090297
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 090297
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 090297 ANDA Teva Pharmaceuticals USA, Inc. 0093-4145 0093-4145-56 6 POUCH in 1 CARTON (0093-4145-56) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4145-45) / 3 mL in 1 VIAL, SINGLE-DOSE
LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 090297 ANDA Teva Pharmaceuticals USA, Inc. 0093-4146 0093-4146-56 6 POUCH in 1 CARTON (0093-4146-56) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4146-45) / 3 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.0103% BASE
Approval Date:Apr 26, 2013TE:ANRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Apr 26, 2013TE:ANRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Apr 26, 2013TE:ANRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.