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- 美国专利到期不等于中国专利到期。本页日期来自美国橙皮书，中国专利状态需另行核查。
- 橙皮书只列持有人申报的专利，未涵盖全部相关专利。
- 中国一侧“未匹配”表示本站已载入的中国官方名称来源中没有该成分的英文名对应，不表示中国没有批准或没有企业申报；“计数为零”表示有中文名但本站来源中未见记录。各源截止时间列于下方。
- 本页不含销售额和市场规模，不能据此判断开发价值。
- 未对接行的药名为 FDA 橙皮书原文，未做中文翻译；同一成分在中国的通用名可能不同。
美国批准产品
保留申请号、产品号及原文字段。已停止销售与原文件上市状态按行展示。
最早批准1982 年前已批准
仿制药申请数44
参比制剂申请人—
当前在售产品数: 49 · 按 FDA 上市状态原文统计处方药及 OTC 产品；停销和未知状态不计入。
| 申请号 / 产品号 | 商品名原文 | 申请人原文 | 剂型原文 | 给药途径原文 | 规格原文 | 最早批准 | RLD / RS | 上市状态原文 | 查看官方来源 |
|---|---|---|---|---|---|---|---|---|---|
| A060180-001 | VANCOCIN HYDROCHLORIDE | STERISCIENCE PTE LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1982 年前已批准 | N / N | DISCONTINUED | openFDA ↗ |
| A060180-002 | VANCOCIN HYDROCHLORIDE | STERISCIENCE PTE LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1986/03/21 | N / N | DISCONTINUED | openFDA ↗ |
| A062476-001 | VANCOCIN HYDROCHLORIDE | STERISCIENCE PTE LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 1984/03/15 | N / N | DISCONTINUED | openFDA ↗ |
| A062476-002 | VANCOCIN HYDROCHLORIDE | STERISCIENCE PTE LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 1986/03/21 | N / N | DISCONTINUED | openFDA ↗ |
| A062663-001 | VANCOMYCIN HYDROCHLORIDE | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 1987/03/17 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062663-002 | VANCOMYCIN HYDROCHLORIDE | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 1987/07/31 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062663-003 | VANCOMYCIN HYDROCHLORIDE | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL | 1988/06/03 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062663-004 | VANCOMYCIN HYDROCHLORIDE | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 1997/11/28 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062663-005 | VANCOMYCIN HYDROCHLORIDE | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 750MG BASE/VIAL | 2016/08/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062682-001 | VANCOLED | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1986/07/22 | N / N | DISCONTINUED | openFDA ↗ |
| A062682-002 | VANCOLED | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1988/03/30 | N / N | DISCONTINUED | openFDA ↗ |
| A062682-003 | VANCOLED | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1988/05/11 | N / N | DISCONTINUED | openFDA ↗ |
| A062682-004 | VANCOLED | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1988/05/11 | N / N | DISCONTINUED | openFDA ↗ |
| A062682-005 | VANCOLED | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1988/05/11 | N / N | DISCONTINUED | openFDA ↗ |
| A062716-001 | VANCOCIN HYDROCHLORIDE | STERISCIENCE PTE LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 1987/03/13 | N / N | DISCONTINUED | openFDA ↗ |
| A062716-002 | VANCOCIN HYDROCHLORIDE | STERISCIENCE PTE LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 1987/03/13 | N / N | DISCONTINUED | openFDA ↗ |
| A062812-001 | VANCOCIN HYDROCHLORIDE | STERISCIENCE PTE LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1987/11/17 | N / N | DISCONTINUED | openFDA ↗ |
| A062812-002 | VANCOCIN HYDROCHLORIDE | STERISCIENCE PTE LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1987/11/17 | N / N | DISCONTINUED | openFDA ↗ |
| A062812-003 | VANCOCIN HYDROCHLORIDE | STERISCIENCE PTE LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1987/11/17 | N / N | DISCONTINUED | openFDA ↗ |
| A062879-001 | VANCOMYCIN HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 1988/08/02 | N / N | DISCONTINUED | openFDA ↗ |
| A062879-002 | VANCOMYCIN HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 1988/08/02 | N / N | DISCONTINUED | openFDA ↗ |
| A062911-001 | VANCOMYCIN HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 1988/08/04 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062912-001 | VANCOMYCIN HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 1988/08/04 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062912-002 | VANCOMYCIN HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 750MG BASE/VIAL | 2009/01/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062912-003 | VANCOMYCIN HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1.5GM BASE/VIAL | 2020/07/10 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062931-001 | VANCOMYCIN HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 1992/10/29 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062933-001 | VANCOMYCIN HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 1992/10/29 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062933-002 | VANCOMYCIN HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 750MG BASE/VIAL | 2009/05/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062956-001 | VANCOR | PHARMACIA AND UPJOHN CO | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 1988/08/01 | N / N | DISCONTINUED | openFDA ↗ |
| A062956-002 | VANCOR | PHARMACIA AND UPJOHN CO | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 1988/08/01 | N / N | DISCONTINUED | openFDA ↗ |
| A063076-001 | VANCOMYCIN HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL | 1990/12/21 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A063076-002 | VANCOMYCIN HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 2020/09/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065397-001 | VANCOMYCIN HYDROCHLORIDE | MYLAN LABORATORIES LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 2008/12/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065397-002 | VANCOMYCIN HYDROCHLORIDE | MYLAN LABORATORIES LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 2008/12/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065401-001 | VANCOMYCIN HYDROCHLORIDE | EUROFARMA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 2008/06/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065401-002 | VANCOMYCIN HYDROCHLORIDE | EUROFARMA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 2008/06/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065432-001 | VANCOMYCIN HYDROCHLORIDE | MYLAN LABORATORIES LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL | 2008/12/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065455-001 | VANCOMYCIN HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 2009/04/29 | N / N | DISCONTINUED | openFDA ↗ |
| A090250-001 | VANCOMYCIN HYDROCHLORIDE | PLANO PHARMACEUTICALS INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 2010/04/27 | N / N | DISCONTINUED | openFDA ↗ |
| A090250-002 | VANCOMYCIN HYDROCHLORIDE | PLANO PHARMACEUTICALS INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 2010/04/27 | N / N | DISCONTINUED | openFDA ↗ |
| A091377-001 | VANCOMYCIN HYDROCHLORIDE | XELLIA PHARMACEUTICALS APS | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 2015/09/09 | N / N | DISCONTINUED | openFDA ↗ |
| A091377-002 | VANCOMYCIN HYDROCHLORIDE | XELLIA PHARMACEUTICALS APS | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 2015/09/09 | N / N | DISCONTINUED | openFDA ↗ |
| A091469-001 | VANCOMYCIN HYDROCHLORIDE | MYLAN LABORATORIES LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 2011/07/01 | N / N | DISCONTINUED | openFDA ↗ |
| A091554-001 | VANCOMYCIN HYDROCHLORIDE | MYLAN LABORATORIES LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 2011/09/19 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A200837-001 | VANCOMYCIN HYDROCHLORIDE | SAGENT PHARMACEUTICALS INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL | 2012/08/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A200837-002 | VANCOMYCIN HYDROCHLORIDE | SAGENT PHARMACEUTICALS INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 2014/09/02 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A201048-001 | VANCOMYCIN HYDROCHLORIDE | PLANO PHARMACEUTICALS INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL | 2012/08/10 | N / N | DISCONTINUED | openFDA ↗ |
| A201048-002 | VANCOMYCIN HYDROCHLORIDE | PLANO PHARMACEUTICALS INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 2012/08/10 | N / N | DISCONTINUED | openFDA ↗ |
| A201250-001 | VANCOMYCIN HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL | 2015/12/23 | N / N | DISCONTINUED | openFDA ↗ |
| A201250-002 | VANCOMYCIN HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 2015/12/23 | N / N | DISCONTINUED | openFDA ↗ |
| A201251-001 | VANCOMYCIN HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 2015/12/23 | N / N | DISCONTINUED | openFDA ↗ |
| A201251-002 | VANCOMYCIN HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 2015/12/23 | N / N | DISCONTINUED | openFDA ↗ |
| A202274-001 | VANCOMYCIN HYDROCHLORIDE | AVET LIFESCIENCES LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL | 2013/10/31 | N / N | DISCONTINUED | openFDA ↗ |
| A202275-001 | VANCOMYCIN HYDROCHLORIDE | AVET LIFESCIENCES LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 2013/10/31 | N / N | DISCONTINUED | openFDA ↗ |
| A202275-002 | VANCOMYCIN HYDROCHLORIDE | AVET LIFESCIENCES LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 2013/10/31 | N / N | DISCONTINUED | openFDA ↗ |
| A202464-001 | VANCOMYCIN HYDROCHLORIDE | AVET LIFESCIENCES LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 2013/10/09 | N / N | DISCONTINUED | openFDA ↗ |
| A203300-001 | VANCOMYCIN HYDROCHLORIDE | HIKMA FARMACEUTICA PORTUGAL SA | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 2020/08/11 | N / N | DISCONTINUED | openFDA ↗ |
| A203300-002 | VANCOMYCIN HYDROCHLORIDE | HIKMA FARMACEUTICA PORTUGAL SA | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 2020/08/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204107-001 | VANCOMYCIN HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 2015/12/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204107-002 | VANCOMYCIN HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 2015/12/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204125-001 | VANCOMYCIN HYDROCHLORIDE | XELLIA PHARMACEUTICALS APS | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL | 2015/12/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204125-002 | VANCOMYCIN HYDROCHLORIDE | XELLIA PHARMACEUTICALS APS | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 2015/12/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204360-001 | VANCOMYCIN HYDROCHLORIDE | HIKMA FARMACEUTICA PORTUGAL SA | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL | 2018/10/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204360-002 | VANCOMYCIN HYDROCHLORIDE | HIKMA FARMACEUTICA PORTUGAL SA | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 2018/10/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205694-001 | VANCOMYCIN HYDROCHLORIDE | GLAND PHARMA LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 2016/01/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205694-002 | VANCOMYCIN HYDROCHLORIDE | GLAND PHARMA LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 2016/01/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205694-003 | VANCOMYCIN HYDROCHLORIDE | GLAND PHARMA LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL | 2023/06/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205694-004 | VANCOMYCIN HYDROCHLORIDE | GLAND PHARMA LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 2023/06/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205779-001 | VANCOMYCIN HYDROCHLORIDE | EUGIA PHARMA SPECIALITIES LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL | 2016/03/29 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205779-002 | VANCOMYCIN HYDROCHLORIDE | EUGIA PHARMA SPECIALITIES LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 2016/03/29 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205780-001 | VANCOMYCIN HYDROCHLORIDE | EUGIA PHARMA SPECIALITIES LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 2016/03/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205780-002 | VANCOMYCIN HYDROCHLORIDE | EUGIA PHARMA SPECIALITIES LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 2016/03/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206243-001 | VANCOMYCIN HYDROCHLORIDE | XELLIA PHARMACEUTICALS APS | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL | 2015/12/23 | N / N | DISCONTINUED | openFDA ↗ |
| A206243-002 | VANCOMYCIN HYDROCHLORIDE | XELLIA PHARMACEUTICALS APS | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 2015/12/23 | N / N | DISCONTINUED | openFDA ↗ |
| A206616-001 | VANCOMYCIN HYDROCHLORIDE | HIKMA PHARMACEUTICALS | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 750MG BASE/VIAL | 2018/10/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212332-001 | VANCOMYCIN HYDROCHLORIDE | HAINAN POLY PHARM CO LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 2019/06/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212332-002 | VANCOMYCIN HYDROCHLORIDE | HAINAN POLY PHARM CO LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 2019/06/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213059-001 | VANCOMYCIN HYDROCHLORIDE | KNACK PHARMACEUTICALS INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 2022/02/15 | N / N | DISCONTINUED | openFDA ↗ |
| A213059-002 | VANCOMYCIN HYDROCHLORIDE | KNACK PHARMACEUTICALS INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 750MG BASE/VIAL | 2022/02/15 | N / N | DISCONTINUED | openFDA ↗ |
| A213059-003 | VANCOMYCIN HYDROCHLORIDE | KNACK PHARMACEUTICALS INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 2022/02/15 | N / N | DISCONTINUED | openFDA ↗ |
| A215195-001 | VANCOMYCIN HYDROCHLORIDE | MEITHEAL PHARMACEUTICALS INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 750MG BASE/VIAL | 2022/09/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215196-001 | VANCOMYCIN HYDROCHLORIDE | MEITHEAL PHARMACEUTICALS INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL | 2022/07/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215196-002 | VANCOMYCIN HYDROCHLORIDE | MEITHEAL PHARMACEUTICALS INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 2022/07/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215197-001 | VANCOMYCIN HYDROCHLORIDE | MEITHEAL PHARMACEUTICALS INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 2022/07/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215197-002 | VANCOMYCIN HYDROCHLORIDE | MEITHEAL PHARMACEUTICALS INC | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 2022/07/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215821-001 | VANCOMYCIN HYDROCHLORIDE | HAINAN POLY PHARM CO LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL | 2021/11/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215821-002 | VANCOMYCIN HYDROCHLORIDE | HAINAN POLY PHARM CO LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL | 2021/11/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216591-001 | VANCOMYCIN HYDROCHLORIDE | ASPIRO PHARMA LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL | 2022/07/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216591-002 | VANCOMYCIN HYDROCHLORIDE | ASPIRO PHARMA LTD | INJECTABLE | INJECTION | VANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL | 2022/07/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
所列美国专利
逐条保留 *PED、物质/制剂标记、用途码及移除请求标记，不据此解释权利效力。
最晚所列专利到期—
物质专利到期（DS 标记）—
此列只汇总来源明确标为物质专利（DS）的行。PED 行若未带 DS 标记，不为其补标或推断。
| 申请号 / 产品号 | 专利号 | 所列到期日 | 物质 / 制剂标记 | 用途码 | 移除请求标记 | 查看官方来源 |
|---|---|---|---|---|---|---|
| 未列出 | ||||||
中国记录明细
查看中国品种页 ↗四项全零只适用于已对接行：目录集持有人、医保批准文号、当前在审、今年新报仿制企业。未对接行不显示中国计数。 件按受理号计，企业按第一申请人计；不同规格可有多个受理号。药名只做全半角与空白归一化，不同通用名、剂型及复方分开；来源未列规格时标注未列。三类企业数不得相加。
目录集持有人 12
| 企业原文 | 编号原文 | 来源日期 | 查看官方来源 |
|---|---|---|---|
| 福安药业集团湖北人民制药有限公司 | 国药准字H202650430.5g（50万单位）（按C66H75Cl2N9O24计） | 2026/06/30 | 查看官方来源 ↗ |
| 安徽省先锋制药有限公司 | 国药准字H202642320.5g（50万单位）（按C66H75Cl2N9O24计） | 2026/05/07 | 查看官方来源 ↗ |
| 华北制药股份有限公司 | 国药准字H202552300.5g（50万单位）（按C66H75Cl2N9O24计） | 2025/08/26 | 查看官方来源 ↗ |
| 海南倍特药业有限公司 | 国药准字H202537810.5g（50万单位）（按C66H75Cl2N9O24计） | 2025/04/01 | 查看官方来源 ↗ |
| 山东鲁抗医药股份有限公司 | 国药准字H202449550.5g（50万单位）（按C66H75Cl2N9O24计） | 2024/09/19 | 查看官方来源 ↗ |
| 南京恒道医药科技股份有限公司 | 国药准字H202448080.5g(50万单位)(按C66H75Cl2N9O24计) | 2024/09/03 | 查看官方来源 ↗ |
| 海南普利制药股份有限公司 | 国药准字H202436600.5g（50万单位）（按C66H75Cl2N9O24计） | 2024/05/08 | 查看官方来源 ↗ |
| 丽珠集团丽珠制药厂 | 国药准字H201933780.5g（50万单位）（按C66H75Cl2N9O24计） | 2023/04/05 | 查看官方来源 ↗ |
| 浙江海正药业股份有限公司 | 国药准字H200842680.5g（50万单位）（按C66H75Cl2N9O24计） | 2021/11/15 | 查看官方来源 ↗ |
| 浙江医药股份有限公司 | 国药准字H200333660.5g（50万单位）（按C66H75Cl2N9O24计） | 2021/06/03 | 查看官方来源 ↗ |
| VANCOCIN ITALIA S.R.L. | H20140174500mg | 1988/10/15 | 查看官方来源 ↗ |
| 重庆药友制药有限责任公司 | 国药准字H202549040.5g（50万单位）（按C66H75Cl2N9O24计） | 2025/07/22 | 查看官方来源 ↗ |
医保批准文号 15
| 企业原文 | 编号原文 | 来源日期 | 查看官方来源 |
|---|---|---|---|
| 丽珠集团丽珠制药厂 | 国药准字H201933780.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| 重庆药友制药有限责任公司 | 国药准字H202549040.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| 华北制药股份有限公司 | 国药准字H202552300.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| 安徽省先锋制药有限公司 | 国药准字H202642320.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| 浙江海正药业股份有限公司 | 国药准字H200842680.5g(50万单位)(按C66H75Cl2N9O24计) | — | 查看官方来源 ↗ |
| 浙江医药股份有限公司新昌制药厂 | 国药准字H200333660.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| 海南倍特药业有限公司 | 国药准字H202537810.5g(50万单位)(按C66H75Cl2N9O24计) | — | 查看官方来源 ↗ |
| 海南普利制药股份有限公司 | 国药准字H202436600.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| 福安药业集团湖北人民制药有限公司 | 国药准字H202650430.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| VANCOCIN ITALIA S.R.L. | 国药准字HJ201401740.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| CJ HealthCare Corporation | H201711320.5g(相当于万古霉素50万单位) | — | 查看官方来源 ↗ |
| Gentle pharma Co.,Ltd. | HC201500540.5g(按万古霉素计) | — | 查看官方来源 ↗ |
| 南京恒道医药科技股份有限公司 | 国药准字H202448080.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| 山东鲁抗医药股份有限公司 | 国药准字H202449550.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| 丽珠集团丽珠制药厂 | 国药准字H201933780.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| 安徽省先锋制药有限公司 | 国药准字H202642320.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| 浙江海正药业股份有限公司 | 国药准字H200842680.5g(50万单位)(按C66H75Cl2N9O24计) | — | 查看官方来源 ↗ |
| 海南倍特药业有限公司 | 国药准字H202537810.5g(50万单位)(按C66H75Cl2N9O24计) | — | 查看官方来源 ↗ |
| 海南普利制药股份有限公司 | 国药准字H202436600.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| 福安药业集团湖北人民制药有限公司 | 国药准字H202650430.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| Gentle pharma Co.,Ltd. | HC201500540.5g(按万古霉素计) | — | 查看官方来源 ↗ |
| 南京恒道医药科技股份有限公司 | 国药准字H202448080.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| 南京恒道医药科技股份有限公司 | 国药准字H202448080.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) | — | 查看官方来源 ↗ |
| 浙江海正药业股份有限公司 | 国药准字H20084269按C66H75Cl2N9O24计1.0g(100万单位) | — | 查看官方来源 ↗ |
| 浙江海正药业股份有限公司 | 国药准字H20084269按C66H75Cl2N9O24计1.0g(100万单位) | — | 查看官方来源 ↗ |
当前在审 4
今年新报仿制企业 4
A 状态原料药企业 6
| 企业原文 | 编号原文 | 来源日期 | 查看官方来源 |
|---|---|---|---|
| 浙江昌海制药有限公司 | Y20230000281 | 2025/03/06 | 查看官方来源 ↗ |
| 浙江医药股份有限公司新昌制药厂 | Y20190009487 | — | 查看官方来源 ↗ |
| 华北制药华胜有限公司 | Y20190006976 | — | 查看官方来源 ↗ |
| 浙江海正药业股份有限公司 | Y20190006263 | 2025/07/04 | 查看官方来源 ↗ |
| 浙江医药股份有限公司新昌制药厂 | Y20180001287 | 2025/03/18 | 查看官方来源 ↗ |
| 丽珠集团福州福兴医药有限公司 | Y20170000276 | 2026/09/03 | 查看官方来源 ↗ |
| 雅赛利(台州)制药有限公司 | Y20170000173 | 2024/10/22 | 查看官方来源 ↗ |
试验登记 2025/2026 —
未载入
来源与截止时间
- FDA 橙皮书
- 2026/11/06
- CDE 受理与在审
- 2026/11/13 06:42
- 化学药品目录集
- 2026/11/13 06:39
- 原辅包登记
- 2026/11/13 06:41
- 医保药品代码库
- 2026/10/23
- 试验登记
- 2026/11/13 08:09 · 覆盖不完整
已对接行按完整成分、剂型与途径计算中国计数；未匹配和部分成分行只列来源对接状态，不推断中国批准或申报情况。试验登记仅覆盖登记号 2025/2026。
剂型通用对应：注射用 X（粉针结构） → INJECTABLE · INJECTION；依据《中国药典》0102 注射剂，对应表行 CHP-FORM-088。
本次对照生成于: 2026/11/13 18:41 · openFDA Orange Book ↗
名称和剂型对接依据
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 26-90 · 2020/06/04
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · CHP-FORM-088 · 0102 注射剂
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