Drug Approval Package
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Ximino
(minocycline hydrochloride) Extended-Release Capsules, 45 mg, 67.5 mg, 90 mg, 112.5 mg, and 135 mg
Company: Ranbaxy Laboratories Limited
Application No.: 201922
Approval Date: 07/11/2012
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Cross Discipline Team Leader Review (PDF)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: August 13, 2013
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