Drug Approval Package
Ventolin-HFA
(Albuterol Sulfate) Inhalation Aerosol
Company: GlaxoSmithKline
Application No.: 20-983
Approval Date: 4/19/2001
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF) -
Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Correspondence (PDF)
Date created: November 20, 2001
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