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ANDA approval times fall by one month

Executive Summary

Median ANDA approval time in fiscal year 2004 was 16.3 months, a one-month improvement over FY 2003, FDA says. The agency issued a total of 413 ANDA approvals (320 final, 93 tentative), which was 40 more than the prior year. The number of original ANDAs received jumped 25% in 2004 to 563...
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