Drug Approval Package
Nicotine Polacrilex Gum, 2mg
Company: Circa Pharmaceuticals, Inc.
Application No.: 74-507
Approval Date: 3/15/1999
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Chemistry Review(s) (PDF)
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Bioequivalence Review(s) (PDF)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF) -
Administrative Document(s) & Correspondence (PDF)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF)