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Drug Approval Package: Cetylev effervescent tablets for oral solution, 500 mg and 2.5 grams (acetylcysteine)

Company: Arbor Pharmaceuticals, LLC
Application No.: 207916Orig1s000
Approval Date: January 29, 2016

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

Approval Letter(s) (PDF)
Printed Labeling (PDF)
Summary Review (PDF)
Officer/Employee List (PDF)
Cross Discipline Team Leader Review (PDF)
Medical Review(s) (PDF)
Chemistry Review(s) (PDF)
Pharmacology Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Other Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)

Date created: November 10, 2016

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