Drug Approval Package
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Tevetan/Eprosartan mesylate
Company: SmithKline Beecham
Application No.: 20738
Approval Date: 12/22/1997
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter [180 KB]
- Medical Review(s)
Part 1 [4.1 MB],
Part 2 [4 MB]
Part 3 [4.4 MB]
Part 4 [4.2 MB]
Part 5 [4.2 MB]
Part 6 [3.7 MB] - Chemistry Review(s) [312 KB]
- EA(Fonsi) [1.5 MB]
- Pharmacology Review(s)
Part 1 [2.9 MB]
Part 2 [3.1 MB] - Statistical Review(s) [2.9 MB]
- Bioequivalence Review(s) [3.6 MB]
- Administrative Documents [1 MB]
Date created: October 20, 1998
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
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