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Details for New Drug Application (NDA): 018062

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NDA 018062 describes PROVENTIL, which is a drug marketed by Schering and 3M and is included in six NDAs. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PROVENTIL profile page.

The generic ingredient in PROVENTIL is albuterol. There are thirty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the albuterol profile page.

Summary for NDA: 018062

albuterol sulfate
Therapeutic Class:Respiratory Tract Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrengthEQ 2MG BASE/5ML
Approval Date:Jan 19, 1983TE:RLD:No

Expired Orange Book Patents for NDA: 018062

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
albuterol sulfate
SYRUP;ORAL018062-001Jan 19, 19833,644,353<disabled>
albuterol sulfate
SYRUP;ORAL018062-001Jan 19, 19834,499,108<disabled>
albuterol sulfate
SYRUP;ORAL018062-001Jan 19, 19833,705,233<disabled>
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