关于FDA《特定药物的生物等效性指导原则》数据库（译文）说明

关于FDA《特定药物的生物等效性指导原则》数据库（译文）说明

2016年05月26日 发布

生物等效性评价是我国进行仿制药质量与疗效一致性评价的重点内容之一，中国药学会和中国食品药品检定研究院组织专家对美国FDA《特定药物的生物等效性指导原则》（Guidance for Industry Bioequivalence Recommendations for Specific Products）的有关内容开展了翻译工作。 本次翻译内容主要为涉及我国进行仿制药质量与疗效一致性评价的首批品种，以期对我国正在开展的仿制药质量与疗效一致性评价工作起到借鉴和指导作用。 本译文稿内容仅供读者参考。如有意见和建议请及时告知，我们将做好数据库后续更新和维护工作。 我们郑重说明，上述译稿仅供仿制药质量和疗效一致性评价相关教学与科研之用，任何人不得进行商业化使用及盈利，否则我们保留追究相关行为人法律责任的权利。 联系人：朱凤昌、曹秀萍（中国药学会，电话 010-58698009-803） 联系邮箱：CPABE@cpa.org.cn 点击查看数据库内容 点击查看FDA《特定药物的生物等效性指导原则》（译文） http://www.nifdc.org.cn/fzy/CL0847/8078.html FDA《特定药物的生物等效性指导原则》数据库参考（译文） 2016年05月17日 发布 序号 药品名称 剂型 原文链接 1 阿苯达唑 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333003.pdf 2 阿卡波糖 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM170242.pdf 3 阿立哌唑 口腔崩解片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194591.pdf 4 阿立哌唑 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM082554.pdf 5 阿莫西林 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM346986.pdf 6 阿莫西林 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM319974.pdf 7 阿莫西林-克拉维酸钾 混悬剂 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM319973.pdf 8 阿莫西林-克拉维酸钾 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM234958.pdf 9 阿普唑仑 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM082449.pdf 10 阿普唑仑 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM082455.pdf 11 阿奇霉素 缓释混悬剂 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM082807.pdf 12 阿奇霉素 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM082824.pdf 13 阿司匹林 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM452688.pdf 14 阿司匹林、盐酸羟考酮和对苯二甲酸羟考酮 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199621.pdf 15 阿替洛尔 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM191773.pdf 16 阿替洛尔和氯噻酮 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM406234.pdf 17 阿昔洛韦 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM296732.pdf 18 阿昔洛韦 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM082352.pdf 19 氨苯蝶啶 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM090716.pdf 20 氨苯砜 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM244378.pdf 21 奥美拉唑 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM320012.pdf 22 白消安 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM082982.pdf 23 苯磺酸氨氯地平 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM082471.pdf 24 苯磺酸氨氯地平-盐酸贝那普利 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM082478.pdf 25 苯妥英钠 缓释胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM428264.pdf 26 苯妥英钠 缓释胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM428265.pdf 27 吡喹酮 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436854.pdf 28 别嘌呤醇 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM148183.pdf 29 丙硫氧嘧啶 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM296986.pdf 30 丙戊酸 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199683.pdf 31 布洛芬 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM234967.pdf 32 布洛芬 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436830.pdf 33 布洛芬 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM204391.pdf 34 布洛芬 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM204392.pdf 35 茶碱 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199678.pdf 36 茶碱 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199679.pdf 37 醋酸甲地孕酮 混悬剂 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199662.pdf 38 醋酸甲地孕酮 混悬剂 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199663.pdf 39 醋酸甲羟孕酮 混悬剂 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358126.pdf 40 醋酸甲羟孕酮 混悬剂 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358133.pdf 41 醋酸泼尼松龙 混悬剂 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199671.pdf 42 醋酸去氨加压素 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM116132.pdf 43 地高辛 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM085610.pdf 44 地塞米松 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM261518.pdf 45 地西泮 凝胶 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM220122.pdf 46 对乙酰氨基酚 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM244364.pdf 47 多西环素 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM406262.pdf 48 多西环素 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM406263.pdf 49 多西环素 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM085682.pdf 50 法莫替丁 混悬剂 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM082257.pdf 51 法莫替丁 口腔崩解片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM086173.pdf 52 法莫替丁 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM086174.pdf 53 奋乃静 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199668.pdf 54 呋喃妥因 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM148233.pdf 55 呋喃妥因 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM296907.pdf 56 呋喃妥因 混悬剂 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM148222.pdf 57 呋塞米 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227421.pdf 58 氟康唑 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM086187.pdf 59 氟哌啶醇 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM082262.pdf 60 富马酸比索洛尔 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM082935.pdf 61 富马酸喹硫平 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM089522.pdf 62 格列本脲 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM296899.pdf 63 格列本脲 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM296898.pdf 64 格列吡嗪 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM224211.pdf 65 格列美脲 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM086202.pdf 66 枸橼酸他莫昔芬 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM162476.pdf 67 骨化三醇 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM083267.pdf 68 红霉素 迟释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM384115.pdf 69 华法林钠 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201283.pdf 70 环孢素 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436816.pdf 71 环孢素 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436817.pdf 72 环磷酰胺 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM319987.pdf 73 磺胺甲恶唑甲氧苄啶 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM090384.pdf 74 磺胺嘧啶 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM090375.pdf 75 甲氨蝶呤 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM148209.pdf 76 甲氨蝶呤 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM148214.pdf 77 甲睾酮 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358138.pdf 78 甲巯咪唑 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199664.pdf 79 甲硝唑 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM481922.pdf 80 甲硝唑 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227424.pdf 81 酒石酸美托洛尔 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM428214.pdf 82 卡马西平 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM270381.pdf 83 克拉霉素 颗粒 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM083330.pdf 84 克拉霉素 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201285.pdf 85 拉米夫定 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM086279.pdf 86 拉米夫定 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM086280.pdf 87 劳拉西泮 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199660.pdf 88 利巴韦林 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM089566.pdf 89 利巴韦林 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM089571.pdf 90 利福平 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM089576.pdf 91 利培酮 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM089591.pdf 92 磷霉素氨丁三醇 混悬剂 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM406270.pdf 93 磷酸伯氨喹 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM452858.pdf 94 硫酸吗啡 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM238059.pdf 95 硫酸吗啡 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201260.pdf 96 硫酸氢氯吡格雷 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM083335.pdf 97 硫唑嘌呤 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227412.pdf 98 柳氮磺胺吡啶 迟释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199673.pdf 99 柳氮磺胺吡啶 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199674.pdf 100 氯氮平 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM249219.pdf 101 氯化钾 缓释胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM270390.pdf 102 氯化钾 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273919.pdf 103 氯化钾 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM277425.pdf 104 氯化钾 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436853.pdf 105 氯雷他定 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM347005.pdf 106 氯雷他定 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM088637.pdf 107 氯硝西泮 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM209229.pdf 108 螺内酯 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194669.pdf 109 马来酸依那普利 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM086242.pdf 110 米司非酮 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM259169.pdf 111 米索前列醇 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199666.pdf 112 奈韦拉平 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM088753.pdf 113 泼尼松 迟释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM373707.pdf 114 泼尼松 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM481947.pdf 115 齐多夫定 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM091318.pdf 116 齐多夫定 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM091325.pdf 117 羟基脲 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM086219.pdf 118 氢化可的松 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM347000.pdf 119 氢氯噻嗪-氨苯蝶啶 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358120.pdf 120 氢氯噻嗪 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM086211.pdf 121 氢氯噻嗪 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM212611.pdf 122 秋水仙碱 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227418.pdf 123 巯嘌呤 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM088658.pdf 124 炔雌醇左炔诺孕酮 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM406266.pdf 125 双氯芬酸钠 迟释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM188527.pdf 126 双氯芬酸钠 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM188529.pdf 127 双嘧达莫 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM085628.pdf 128 司他夫定 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM090340.pdf 129 碳酸锂 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM088629.pdf 130 碳酸锂 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201253.pdf 131 替硝唑 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM090628.pdf 132 头孢氨苄 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM148189.pdf 133 头孢呋辛酯 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM224201.pdf 134 维A酸 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227434.pdf 135 硝苯地平 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM320010.pdf 136 硝苯地平 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM118368.pdf 137 硝苯地平 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM261522.pdf 138 硝酸甘油 舌下片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM205304.pdf 139 硝酸异山梨酯 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436834.pdf 140 硝酸异山梨酯 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436835.pdf 141 缬沙坦 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM091254.pdf 142 辛伐他汀 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM089631.pdf 143 熊去氧胆酸 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199681.pdf 144 熊去氧胆酸 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM091238.pdf 145 溴吡斯的明 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM179187.pdf 146 盐酸阿米替林 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM204378.pdf 147 盐酸胺碘酮 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM238049.pdf 148 盐酸昂丹司琼 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM089250.pdf 149 盐酸苯海拉明 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM406261.pdf 150 盐酸地尔硫卓 缓释胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM085618.pdf 151 盐酸地尔硫卓 缓释胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM085614.pdf 152 盐酸地尔硫卓 缓释胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM085621.pdf 153 盐酸多塞平 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227419.pdf 154 盐酸多塞平 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM224207.pdf 155 盐酸多塞平 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436824.pdf 156 盐酸二甲双胍 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM088677.pdf 157 盐酸二甲双胍 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM118355.pdf 158 盐酸二甲双胍 缓释片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM118362.pdf 159 盐酸二甲双胍 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM088672.pdf 160 盐酸环丙沙星 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227416.pdf 161 盐酸甲氧氯普胺 口腔崩解片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227423.pdf 162 盐酸甲氧氯普胺 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM162435.pdf 163 盐酸金刚烷胺 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM238047.pdf 164 盐酸克林霉素 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273911.pdf 165 盐酸雷尼替丁 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM191786.pdf 166 盐酸雷尼替丁 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM191788.pdf 167 盐酸氯丙嗪 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM296739.pdf 168 盐酸氯米帕明 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM460986.pdf 169 盐酸帕罗西汀 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM089264.pdf 170 盐酸普罗帕酮 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM162469.pdf 171 盐酸普萘洛尔 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM249252.pdf 172 盐酸坦洛新 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM090564.pdf 173 盐酸特拉唑嗪 胶囊 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM090584.pdf 174 盐酸维拉帕米 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM091264.pdf 175 盐酸乙胺丁醇 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM086254.pdf 176 盐酸异丙嗪 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201269.pdf 177 依非韦伦 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM086239.pdf 178 乙胺嘧啶 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436856.pdf 179 乙酰唑胺 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM082347.pdf 180 异烟肼 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM086266.pdf 181 吲达帕胺 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM086263.pdf 182 制霉素 混悬剂 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM234972.pdf 183 左甲状腺素钠 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM428208.pdf 184 左炔诺孕酮 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM240973.pdf 185 左氧氟沙星 片 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM086291.pdf

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