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标题: 醋酸甲地孕酮片原研药选择 [打印本页]

作者: xiaoxiao    时间: 2016-9-20 12:12 AM
标题: 醋酸甲地孕酮片原研药选择
本帖最后由 xiaoxiao 于 2016-9-20 12:19 AM 编辑

醋酸甲地孕酮片原研药选择




醋酸甲地孕酮片国产规格有40、80、160mg,剂型有片剂、胶囊。
原研药分析:
1.美国橙皮书
   Megace 混悬液40mg/ml,RLD为Bristol myer squibb;醋酸甲地孕酮片40mg,RLD为PAR PHARM公司生产的仿制药。
Active Ingredient:MEGESTROL ACETATE
Dosage Form;Route:SUSPENSION;ORAL
Proprietary Name:MEGACE
Applicant:BRISTOL MYERS SQUIBB
Strength:40MG/ML

Application Number:N020264
Product Number:001
Approval Date:Sep 10, 1993
Reference Listed DrugYes
RX/OTC/DISCN:RX
TE Code:AB
atent and Exclusivity Info for this product:
[url=http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=020264&roduct_No=001&table1=OB_Rx]View
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[/url]
Active Ingredient:MEGESTROL ACETATE
Dosage Form;Route:TABLET;ORAL
Proprietary Name:MEGESTROL ACETATE
ApplicantAR PHARM
Strength:40MG
Application Number:A072423
Product Number:001
Approval Date:Aug 8, 1988
Reference Listed DrugYes

RX/OTC/DISCN:RX
TE Code:AB
atent and Exclusivity Info for this product:
[url=http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=072423&roduct_No=001&table1=OB_Rx]View
-----------------------------------------------------------------------------------------------​
[/url]
[url=http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=072423&roduct_No=001&table1=OB_Rx][/url]
[url=http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=020264&roduct_No=001&table1=OB_Rx][/url]醋酸甲地孕酮片160mg美国橙皮书未见原研药,查英国有上市但不是施贵宝厂家
说明书
http://www.medicines.ie/searchresults.aspx?term=megace&searchtype=AdvancedSearch#ORIGINAL








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