FDA Approved Drug Products provides quick access to official information about FDA-approved new drugs, generics and therapeutic biological products.
2.4 Inactive Ingredient Search for Approved Drug Products Search（被批准药物的非活性成分数据库）点击“图3”中“Inactive Ingredient Search for Approved Drug Products Search”进入非活性成分数据库进行检索。▲ 图-17 以“Lactose”为例，可获得该辅料的Maximum Potency per unit dose和Maximum daily exposure...
橙皮书(Approved Drug Products,电子版) 应该说,这是FDA网站的涉及药学最精华部分,是国内新药研究工作者、特别是把握国内外药学进展的智囊们最关心的部分。该栏目更新很快,且系统、权威而全面。进入橙皮书网页后,可以根据4个线索来查寻(活性成份、专有名、申请人、申请号),以点击“...
2.4 Inactive Ingredient Search for Approved Drug Products Search(被批准药物的非活性成分数据库)点击“图3”中“Inactive Ingredient Search for Approved Drug Products Search”进入非活性成分数据库进行检索。 ▲图-17 以“Lactose”为例,可获得该辅料的Maximum Potency per unit dose和Maximum daily exposure (MDE...
2.4 Inactive Ingredient Search for Approved Drug Products Search(被批准药物的非活性成分数据库) 点击“图3”中“Inactive Ingredient Search for Approved Drug Products Search”进入非活性成分数据库进行检索。 ▲图-17 以“Lactose”为例,可获得该辅料的Maximum Potency per unit dose和Maximum daily exposure (...
点击“图3”中“Inactive Ingredient Search for Approved Drug Products Search”进入非活性数据库检索页,网址:网页链接, 如“图11”所示进行精确检索或模糊检索。 图11 以“BALSAM PERU”为例,在“图11”中精确检索栏输入“BALSAM PERU”输入,检索,弹出检索的信息,如“图12”。
1.https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 2.https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2023-biological-license-application-a...
There are Drug products approved by the U.S. Food and Drug Administration Abbreviations: A/ANDA: Abbreviated New Drug Application Discn: discontinued Drugs N/NDA: New Drug Application, OTC: Over the Counter RLD: reference listed drug Rx: Prescription Drug TE: Therapeutic Equivalence Code, NDA: ...
点击“图3”中“Inactive Ingredient Search for Approved Drug Products Search”进入非活性数据库检索页,网址:https://www.accessdata./scripts/cder/iig/index.cfm, 如“图11”所示进行精确检索或模糊检索。 图11 以“BALSAM PERU”为例,在“图11”中精确检索栏输入“BALSAM PERU”输入,检索,弹出检索的信息,如...
点击“图3”中“Inactive Ingredient Search for Approved Drug Products Search”进入非活性数据库检索页,网址:accessdata.fda.gov/scri, 如“图11”所示进行精确检索或模糊检索。 图11 以“BALSAM PERU”为例,在“图11”中精确检索栏输入“BALSAM PERU”输入,检索,弹出检索的信息,如“图12”。 图12 以“G”...