Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 012339

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BRONKOSOL (ISOETHARINE HYDROCHLORIDE)
0.25%
Marketing Status: Discontinued

Active Ingredient: ISOETHARINE HYDROCHLORIDE
Proprietary Name: BRONKOSOL
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: 0.25%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N012339
Product Number: 009
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

BRONKOSOL (ISOETHARINE HYDROCHLORIDE)
1%
Marketing Status: Discontinued

Active Ingredient: ISOETHARINE HYDROCHLORIDE
Proprietary Name: BRONKOSOL
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: 1%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N012339
Product Number: 008
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

BRONKOMETER (ISOETHARINE MESYLATE)
0.34MG/INH
Marketing Status: Discontinued

Active Ingredient: ISOETHARINE MESYLATE
Proprietary Name: BRONKOMETER
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.34MG/INH
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N012339
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information