Drug Approval Package

Sandostatin Lar Depot (Octreotide Acetate) Injection
Company:  Novartis Pharmaceutical Corporation
Application No.:  021-008
Approval Date: 11/25/1998

• Approval Letter & Final Printed Labeling  (PDF) (1.8 MB)

• Medical Review(s)
  Part 1 (PDF) (2.6 MB)
  Part 2 (PDF) (2.3 MB)
  Part 3 (PDF) (2.8 MB)

• Chemistry Review(s) (PDF) (217 KB)

• Pharmacology Review(s) (PDF) (2.9 MB)

• Statistical Review(s) & Microbiology Review(s) (PDF) (2 MB)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (1.6 MB)

• Administrative Document(s)/Correspondence
  Part 1 (PDF) (2 MB)
  Part 2 (PDF) (2.1 MB)

Date created: March 30, 2001; last update: July 1, 2005

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