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Levalbuterol hydrochloride - Generic Drug Details

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Levalbuterol hydrochloride is the generic ingredient in two branded drugs marketed by Mylan Speclt, Oak Pharms Inc, Ritedose Corp, Watson Labs Inc, Cipla Ltd, Teva Parenteral, and Teva Pharms Usa, and is included in eight NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for levalbuterol hydrochloride. Eleven suppliers are listed for this compound.

Summary for Generic Name: levalbuterol hydrochloride

Tradenames:2
Patents:1
Applicants:7
NDAs:8
Drug Master File Entries: see list9
Suppliers / Packaging: see list11
Therapeutic Class:Respiratory Tract Agents

Pharmacology for Ingredient: levalbuterol hydrochloride

Clinical Trials for: levalbuterol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cipla Ltd
LEVALBUTEROL HYDROCHLORIDE
levalbuterol hydrochloride
SOLUTION;INHALATION078171-001Dec 13, 2013RXNo<disabled><disabled>
Mylan Speclt
LEVALBUTEROL HYDROCHLORIDE
levalbuterol hydrochloride
SOLUTION;INHALATION078309-001Mar 20, 2009RXNo<disabled><disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-002Mar 25, 1999RXYes6,451,289<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: levalbuterol hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-001Mar 25, 19995,760,090<disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-003Jan 30, 20025,547,994<disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-002Mar 25, 19995,844,002<disabled>
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