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2006P-0070
CP 1
Volume 1

Citizen Petition

Tab 1 - USB Monograph for azithromycin Published Material

Tab 2 - Teva azithromycin tablet label Published Material

Tab 3 - Sandoz azithromycin tablet label Published Material

Tab 4 - Analytical tests conducted by Pfizer that indicate Teva's azithromycin product contains, in addition to azithromycin monohyradte hemi-ethanolate, significant amounts of azithromycin sesquihydrate (over 20%)

Tab 5 - Analytical tests that demonstrate Sandoz's product contains only azithromycin sesquihydrate and no detectable azithromycin dihydrate

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Page last updated February 9, 2006 RSChorizonal rule
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