Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021457

PROAIR HFA (ALBUTEROL SULFATE)
EQ 0.09MG BASE/INH Marketing Status: Prescription

Active Ingredient: ALBUTEROL SULFATE
Proprietary Name: PROAIR HFA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: EQ 0.09MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: BX
Application Number: N021457
Product Number: 001
Approval Date: Oct 29, 2004
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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