{"id":45161,"date":"2018-09-20T01:00:00","date_gmt":"2018-09-26T01:15:02","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/26\/%e8%bf%9950%e4%b8%aa%e4%bb%8a%e5%b9%b4%e8%8e%b7%e6%89%b9%e7%9a%84anda%e6%88%96%e8%bd%ac%e6%8a%a5%e5%9b%bd%e5%86%85\/"},"modified":"2018-09-26T09:15:09","modified_gmt":"2018-09-26T01:15:09","slug":"%e8%bf%9950%e4%b8%aa%e4%bb%8a%e5%b9%b4%e8%8e%b7%e6%89%b9%e7%9a%84anda%e6%88%96%e8%bd%ac%e6%8a%a5%e5%9b%bd%e5%86%85","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/45161\/","title":{"rendered":"\u8fd950\u4e2a\u4eca\u5e74\u83b7\u6279\u7684ANDA\u6216\u8f6c\u62a5\u56fd\u5185"},"content":{"rendered":"
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\u4e2d\u56fd\u836f\u4f012018\u81f3\u4eca\u5e74\u83b7\u5f97\u7684ANDA\uff0c\u622a\u6b6209\/12\/2018<\/span><\/p>\n

\"\u8fd950\u4e2a\u4eca\u5e74\u83b7\u6279\u7684ANDA\u6216\u8f6c\u62a5\u56fd\u5185\"<\/p>\n

\"\u8fd950\u4e2a\u4eca\u5e74\u83b7\u6279\u7684ANDA\u6216\u8f6c\u62a5\u56fd\u5185\"<\/p>\n

\"\u8fd950\u4e2a\u4eca\u5e74\u83b7\u6279\u7684ANDA\u6216\u8f6c\u62a5\u56fd\u5185\"<\/p>\n

\"\u8fd950\u4e2a\u4eca\u5e74\u83b7\u6279\u7684ANDA\u6216\u8f6c\u62a5\u56fd\u5185\"<\/p>\n

\u6ce8\uff1a<\/span><\/p>\n

1. Aucta Pharmaceuticals, Inc. (AUCTA\uff0c\u5965\u79d1\u8fbe\u5728\u62c9\u4e01\u8bed\u4e2d\u7684\u610f\u601d\u662f\u201c \u6539\u8fdb\u7684\u201d\uff0c\u201c\u66f4\u597d\u7684\u201d)\uff1b<\/span><\/p>\n

2. SCIECURE PHARMA INC\uff0c\u4e16\u6865\u751f\u7269\uff0c\u5e03\u5730\u5948\u5fb7\u80f6\u56ca3mg\u4e8e2017\u5e7409\u670828\u65e5\u83b7\u7f8e\u56fdFDA\u4e0a\u5e02\u8bb8\u53ef\uff08ANDA\uff09\uff0c\u4e16\u6865\u751f\u7269\u7b2c\u4e00\u4e2a\u83b7\u5f97ANDA\u7684\u4ea7\u54c1\uff1b<\/span><\/p>\n

3. HONG KONG\uff0c\u516c\u53f8\u6bcd\u516c\u53f8\u4e3a\u5357\u4eac\u5065\u53cb\uff0c\u540d\u5b57\u6bd4\u8f83\u9690\u853d\uff1b<\/span><\/p>\n

4. AIPING PHARM INC\uff0c\u7231\u5e73\u5236\u836f\uff0c\u4e0d\u8ba4\u771f\u8fd8\u770b\u4e0d\u51fa\u662f\u56fd\u5185\u4f01\u4e1a\u2026,\u5b89\u58eb\u5236\u836fA&Z Pharmaceutical\uff0c\u96b6\u5c5e\u4e8e\u767e\u6d0b\u533b\u836f\u96c6\u56e2\uff1b<\/span><\/p>\n

5. TWI PHARMS\u6765\u81ea\u6211\u56fd\u53f0\u6e7e\u5730\u533a\uff1b<\/span><\/p>\n

6. \u6682\u65f6\u6027\u6279\u51c6\uff08Tentative Approval\uff09\u7684\u4f01\u4e1a\u54c1\u79cd\u670912\u4e2a\uff1b<\/span><\/p>\n

7. <\/span>2018\u5e749\u670812\u65e5\uff0c\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u516c\u544a\uff0c\u5176\u5236\u5242\u4ea7\u54c1\u76d0\u9178\u4e8c\u7532\u53cc\u80cd\u7f13\u91ca\u7247\u83b7\u5f97\u7f8e\u56fdFDA\u6279\u51c6\u6587\u53f7\u3002<\/span><\/p>\n

\u76d0\u9178\u4e8c\u7532\u53cc\u80cd\u7f13\u91ca\u7247\u7531\u767e\u65f6\u7f8e\u65bd\u8d35\u5b9d\u516c\u53f8\uff08Bristol Myers Squibb\uff09\u7814\u53d1\uff0c\u4e8e2000\u5e74\u5728\u7f8e\u56fd\u4e0a\u5e02\u3002\u76ee\u524d\u5728\u4e2d\u56fd\u5e02\u573a\uff0c\u4e5f\u6709\u591a\u5bb6\u836f\u4f01\u751f\u4ea7\u8be5\u4ea7\u54c1\u3002\u534e\u6d77\u836f\u4e1a\u76ee\u524d\u5728\u76d0\u9178\u4e8c\u7532\u53cc\u80cd\u7f13\u91ca\u7247\u9879\u76ee\u4e0a\u5df2\u6295\u5165\u7814\u53d1\u8d39\u7528\u7ea6600\u4e07\u5143\u4eba\u6c11\u5e01;<\/span><\/p>\n

8. https:\/\/www.fda.gov\/Drugs\/InformationOnDrugs\/ApprovedDrugs\/ApprovedDrugProductswithTherapeuticEquivalenceEvaluationsOrangeBook\/default.htm\uff1bhttps:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm?event=reportsSearch.process\uff1b<\/span>
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\u53c2\u8003\uff1a<\/strong><\/span><\/p>\n

FDA\uff1b<\/strong><\/strong><\/span><\/p>\n

\u836f\u878d\u6570\u636e\uff0cPharnex  Datamonitor\uff1b<\/span><\/strong><\/span><\/p>\n

\u76f8\u5173\u516c\u53f8\u516c\u5f00\u62ab\u9732\u7b49\u3002<\/span><\/p>\n


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\"\u8fd950\u4e2a\u4eca\u5e74\u83b7\u6279\u7684ANDA\u6216\u8f6c\u62a5\u56fd\u5185\"<\/p>\n


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\u836f\u878d\u5708\u4e3a\u836f\u7269\u7b80\u8baf\u5408\u4f5c\u5e73\u53f0.<\/span>
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\u4e2d\u56fd\u836f\u4f012018\u81f3\u4eca\u5e74\u83b7\u5f97\u7684ANDA\uff0c\u622a\u6b6209\/12\/2018 \u6ce8\uff1a 1. Aucta Pharma […]<\/p>\n","protected":false},"author":1,"featured_media":45162,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/45161"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=45161"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/45161\/revisions"}],"predecessor-version":[{"id":45168,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/45161\/revisions\/45168"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/45162"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=45161"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=45161"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=45161"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}