Drug Approval Package
ZyrZyrtec-D 12 hr. Extended-Release Tablets (Cetirizine Hydrochloride
& Pseudoephedrine Hydrochloride)
Company: Pfizer Pharmaceuticals
Application No.: 21-150
Approval Date: 8/10/2001
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
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Chemistry Review(s) (PDF)
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Environmental Assessment (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Date created: November 20, 2001
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