Actos (Pioglitazone Hydrochloride) Tablets
Company:  Takeda Armerica Research & Dev. Ctr. Inc.
Application No.:  021073
Approval Date: 7/15/1999

• Approval Letter(s) (995 KB)

• Final Printed Labeling
  Part 1 ( MB)
  Part 2 ( MB)

• Medical Review(s)
  Part 1 (3 MB)
  Part 2 (2.4 MB)
  Part 3 (2.6 MB)

• Chemistry Review(s) (448 KB)

• Pharmacology Review(s)

  Part 1 (2.7 MB)	Part 4 (2.6 MB)	Part 7 (2.4 MB)
  Part 2 (3 MB)	Part 5 (2.7 MB)	Part 8 (2.1 MB)
  Part 3 (3 MB)	Part 6 (2.2 MB)

• Statistical Review(s)
  Part 1 (2.9 MB)
  Part 2 (2.6 MB)
  Part 3 (2.3 MB)
  Part 4 (2.4 MB)
  Part 5 (2.4 MB)

• Clinical Pharmacology Biopharmaceutics Review(s)
  Part 1 (2.7 MB)
  Part 2 (2.9 MB)
  Part 3 (2.9 MB)
  Part 4 (2.4 MB)

• Administrative Document(s)/Correspondence
  Part 1 (2.7 MB)
  Part 2 (2.8 MB)
  Part 3 (3 MB)
  Part 4 (2.8 MB)

Back to Top     Back to Drugs@FDA

PDF requires the free Adobe Acrobat Reader

Date created: March 30, 2001

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA/Center for Drug Evaluation and Research