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williamxiang木蟲(chóng) (著名寫(xiě)手)
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[求助]
求QSYMIA的CDER評(píng)審文件
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| 求美國(guó)FDA藥品評(píng)審中心(Center for Drug Evaluation and Research)對(duì)Qsymia給出的評(píng)審意見(jiàn)文件。我找了好久沒(méi)有找到。 |
木蟲(chóng) (正式寫(xiě)手)
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http://www.accessdata.fda.gov/dr ... 2580Origs000ltr.pdf http://www.accessdata.fda.gov/dr ... 2/022580s000lbl.pdf Drug Name(s) QSYMIA FDA Application No. (NDA) 022580 Active Ingredient(s) PHENTERMINE; TOPIRAMATE Company VIVUS Original Approval or Tentative Approval Date July 17, 2012 Chemical Type 4 New combination Review Classification S Standard review drug There are no Therapeutic Equivalents Label Information Approval History, Letters, Reviews, and Related Documents REMS10 Medication Guide11 Products on Application (NDA) #022580 Click on a column header to re-sort the table: Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code QSYMIA PHENTERMINE; TOPIRAMATE 3.75MG/23MG CAPSULE, EXTENDED RELEASE; ORAL Prescription TBD 12 TBD 13 QSYMIA PHENTERMINE; TOPIRAMATE 7.5MG/46MG CAPSULE, EXTENDED RELEASE; ORAL Prescription TBD 14 TBD 15 QSYMIA PHENTERMINE; TOPIRAMATE 11.25MG/69MG CAPSULE, EXTENDED RELEASE; ORAL Prescription TBD 16 TBD 17 QSYMIA PHENTERMINE; TOPIRAMATE 15MG/92MG CAPSULE, EXTENDED RELEASE; ORAL Prescription TBD 18 TBD 19 |
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