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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020503

PROVENTIL-HFA (ALBUTEROL SULFATE)
EQ 0.09MG BASE/INH
Marketing Status: Prescription
Active Ingredient: ALBUTEROL SULFATE
Proprietary Name: PROVENTIL-HFA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: EQ 0.09MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB1
Application Number: N020503
Product Number: 001
Approval Date: Aug 15, 1996
Applicant Holder Full Name: KINDEVA DRUG DELIVERY LP
Marketing Status:  Prescription
Patent and Exclusivity Information
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