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发布于 2007-07-06 · 浏览 1.0 万 · IP 海南海南
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The Federal Food, Drug, and Cosmetic Act and FDA regulations permit the submission of ANDAs for drug products that differ in dosage form compared to a listed drug. 21 U.S.C. 5 355(j) (2) (C); 21 C.F.R. $9 314.93, 5.10. FDA has recently approved a number of ANDA suitability petitions seeking comparable dosage form change from tablet to orally disintegrating tablet.
The Federal Food, Drug, and Cosmetic Act and FDA regulations permit the submission of ANDAs for drug products that differ in dosage form compared to a listed drug. 21 U.S.C. 5 355(j) (2) (C); 21 C.F.R. $9 314.93, 5.10. FDA has recently approved a number of ANDA suitability petitions seeking comparable dosage form change from tablet to orally disintegrating tablet.
最后编辑于 2009-05-25 · 浏览 1.0 万
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