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noya
March 2, 2011 Handa Pharmaceuticals, LLC (“Handa”), a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application (“ANDA”) for Dexlansoprazole Delayed Release Capsules, 60 mg, a generic version of Takeda’s DEXILANT®, has been accepted for review by the U.S. Food and Drug Administration (“FDA”). Based upon available information, Handa...
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December 13, 2010 Handa Pharmaceuticals, LLC (“Handa”), a specialty pharmaceutical company based in Fremont, California, today announced that the U.S. Food and Drug Administration (“FDA”) has granted tentative approval of the Company’s Abbreviated New Drug Application (“ANDA”) for Quetiapine Fumarate Extended-Release Tablets, 50 mg., 150 mg., 200 mg., 300 mg., and 400 mg., a generic...
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July 31, 2008 Handa Pharmaceuticals, LLC (“Handa”), a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application (“ANDA”) for Quetiapine Fumarate Extended-Release Tablets, the generic version of AstraZeneca’s SEROQUEL® XR, has been accepted for filing by the U.S. Food and Drug Administration (“FDA”). Based upon available information, Handa believes...
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