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Details for New Drug Application (NDA): 019383

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NDA 019383 describes PROVENTIL, which is a drug marketed by Schering and 3M and is included in six NDAs. There is one patent 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-seven 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: 019383

Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Summary for product number 001

Approval Date:Jul 13, 1987TE:RLD:No

Expired Orange Book Patents for NDA: 019383

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
albuterol sulfate
TABLET, EXTENDED RELEASE;ORAL019383-001Jul 13, 19873,644,353► Subscribe
albuterol sulfate
TABLET, EXTENDED RELEASE;ORAL019383-001Jul 13, 19873,705,233► Subscribe
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