FUSILEV

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十二月 11, 2017

药品名： FUSILEV ANDA/NDA: 20140 公司名称（英语）： SPECTRUM PHARMS 活性物质: LEVOLEUCOVORIN CALCIUM 剂量： EQ 50MG BASE/VIAL;EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**;EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product wa

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药品名: FUSILEV

活性物质: LEVOLEUCOVORIN CALCIUM

剂量: EQ 50MG BASE/VIAL;EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**;EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product waȀ뗐挻畼र�挿畼र蚘ठ籰璜ᩘŭ籰璜ū蚘ठItem츆

销售状态: Prescription

ANDA/NDA: 20140

批准日期: 03/07/2008

提交类型: ORIG-1

剂型: POWDER;IV (INFUSION)

TE代码: AP

RLD: Yes

RS: Yes

公司名称（英文）: SPECTRUM PHARMS

审核意见: Approval

批准信息文件: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140lbl.pdf

药品详细信息: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=20140