Drug Approval Package

Cetraxal (ciprofloxacin otic solution) 0.2%
Company: Laboratories SALVAT, S.A.
Application No.: 021918
Approval Date: 5/1/2009

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Approval Letter(s) (PDF)
Summary Review
- Part 1 (PDF)
- Part 2 (PDF)
Officer/Employee List (PDF)
Cross Discipline Team Leader Review
- Part 1 (PDF)
- Part 2 (PDF)
- Part 3 (PDF)
Printed Labeling (PDF)
Medical Review(s)
- Part 1 (PDF)
- Part 2 (PDF)
- Part 2a (PDF)
- Part 3 (PDF)
- Part 4 (PDF)
- Part 5 (PDF)
- Part 6 (PDF)
- Part 7 (PDF)
Chemistry Review(s)
- Part 1 (PDF)
- Part 2 (PDF)
- Part 3 (PDF)
Pharmacology Review(s) (PDF)
Statistical Review(s)
- Part 1 (PDF)
- Part 2 (PDF)
Microbiology 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)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Proprietary Name Review(s)
- Part 1 (PDF)
- Part 2 (PDF)
- Part 3 (PDF)
- Part 4 (PDF)
Other Action Letter(s) (PDF)
Other Review(s) (PDF)
Administrative Document(s) & Correspondence
- Part 1 (PDF)
- Part 2 (PDF)
- Part 3 (PDF)
- Part 4 (PDF)
- Part 5 (PDF)
- Part 6 (PDF)

Date created: October 6, 2009

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