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Dr. Reddy's Files Manufacturing Application For AstraZeneca's Seroquel

Law360 (April 16, 2004, 12:00 AM EDT) -- Indian drug maker Dr. Reddy’s has filed a manufacturing application with the U.S. Food and Drug Administration for a generic version of U.K.-Swedish pharmaceutical giant AstraZeneca’s schizophrenia drug Seroquel.

The filing for the drug, whose scientific name is quetiapine, was posted on the FDA’s website on Thursday. However, the posting indicated the application by Dr. Reddy's was made in January this year.

The submission of a Drug Master File with the FDA typically precedes an abbreviated new drug application (ANDA). An ANDA for the drug has...
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