Drug Approval Package

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Drug Approval Package

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Exubera (insulin human [rDNA origin] inhalation powder) and Exubera Inhaler
Company: Pfizer Global Research & Development
NDA: 021868
Approval Date: 1/27/2006

Approval Letter(s) (PDF)
Printed Labeling (PDF)
Medical Review(s)
- Part 1 (PDF)
- Part 2 (PDF)
- Part 3 (PDF)
- Part 4 (PDF)
- Part 5 (PDF)
- Part 6 (PDF)
- Part 7 (PDF)
- Part 8 (PDF)
- Part 9 (PDF)
- Part 10 (PDF)
Chemistry Review(s) (PDF)
Environmental Assessment (PDF)
Pharmacology Review(s) (PDF)
Statistical Review(s)
- Part 1 (PDF)
- Part 2 (PDF)
- Part 3 (PDF)
Microbiology Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Administrative Document(s) and Correspondence (PDF)

Date created: October 3, 2008

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