产品信息
| 产品号 | 商品名 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 参比药物(RLD) | 生物等效参考标准(RS) | 治疗等效代码 | 该申请号批准日期 | 该产品号批准日期 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|
| 002 | DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 50MG/ML | Yes | Yes | AP | 1971/02/12 | Approved Prior to Jan 1, 1982 | Prescription |
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|---|---|---|---|---|---|
| 1971/02/12 | ORIG-1（原始申请） | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|---|---|---|---|---|---|
| 2025/06/09 | SUPPL-231（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2016/02/23 | SUPPL-220（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2013/09/05 | SUPPL-218（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2006/10/26 | SUPPL-182（补充） | Approval | Labeling-Container/Carton Labels | N/A | ||
| 2005/09/02 | SUPPL-178（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 2002/11/08 | SUPPL-174（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2002/04/03 | SUPPL-173（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2002/04/03 | SUPPL-172（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2000/03/06 | SUPPL-170（补充） | Approval | Labeling | STANDARD | ||
| 2000/03/03 | SUPPL-171（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1999/06/04 | SUPPL-169（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1998/10/29 | SUPPL-168（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1997/08/21 | SUPPL-167（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1997/08/20 | SUPPL-165（补充） | Approval | Labeling | STANDARD | ||
| 1997/06/11 | SUPPL-166（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1997/03/28 | SUPPL-164（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/08/29 | SUPPL-160（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/08/27 | SUPPL-159（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/08/06 | SUPPL-163（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/03/04 | SUPPL-162（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1995/08/18 | SUPPL-161（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1995/08/14 | SUPPL-157（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1994/05/24 | SUPPL-156（补充） | Approval | Labeling | STANDARD | ||
| 1992/01/28 | SUPPL-152（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1991/09/10 | SUPPL-151（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1991/08/30 | SUPPL-153（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1990/02/22 | SUPPL-148（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1990/01/11 | SUPPL-149（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1989/06/14 | SUPPL-147（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1988/10/17 | SUPPL-145（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1988/08/31 | SUPPL-107（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1988/08/08 | SUPPL-146（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1987/07/30 | SUPPL-142（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1986/11/26 | SUPPL-141（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1986/08/08 | SUPPL-140（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1986/02/21 | SUPPL-139（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1986/01/18 | SUPPL-138（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/11/29 | SUPPL-111（补充） | Approval | Labeling | |||
| 1985/11/29 | SUPPL-110（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/11/07 | SUPPL-133（补充） | Approval | Labeling | |||
| 1985/10/29 | SUPPL-109（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1985/10/26 | SUPPL-125（补充） | Approval | Labeling | |||
| 1985/10/26 | SUPPL-121（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/09/30 | SUPPL-132（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1985/09/26 | SUPPL-115（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1985/08/27 | SUPPL-130（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1985/06/21 | SUPPL-135（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/06/10 | SUPPL-134（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/05/03 | SUPPL-122（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/01/18 | SUPPL-120（补充） | Approval | Labeling | |||
| 1985/01/18 | SUPPL-119（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/01/08 | SUPPL-106（补充） | Approval | Labeling | |||
| 1985/01/08 | SUPPL-105（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/11/28 | SUPPL-108（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/10/22 | SUPPL-116（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/10/17 | SUPPL-101（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/10/10 | SUPPL-92（补充） | Approval | Labeling | |||
| 1984/10/10 | SUPPL-91（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1984/09/25 | SUPPL-102（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/06/14 | SUPPL-103（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1984/04/09 | SUPPL-104（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/03/21 | SUPPL-100（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/03/01 | SUPPL-89（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/02/17 | SUPPL-95（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1983/12/08 | SUPPL-97（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1983/09/19 | SUPPL-96（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1983/08/31 | SUPPL-99（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1983/06/06 | SUPPL-94（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1983/02/15 | SUPPL-88（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1983/01/25 | SUPPL-93（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1983/01/17 | SUPPL-98（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1982/07/26 | SUPPL-90（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1982/07/08 | SUPPL-87（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1982/07/08 | SUPPL-75（补充） | Approval | Labeling | |||
| 1982/06/09 | SUPPL-83（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1982/02/22 | SUPPL-86（补充） | Approval | Labeling | |||
| 1982/02/01 | SUPPL-85（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1982/01/08 | SUPPL-84（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/10/21 | SUPPL-81（补充） | Approval | Labeling | |||
| 1981/10/21 | SUPPL-80（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/10/07 | SUPPL-82（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/09/16 | SUPPL-79（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/07/31 | SUPPL-78（补充） | Approval | Labeling | |||
| 1981/07/31 | SUPPL-77（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/07/16 | SUPPL-69（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/03/02 | SUPPL-76（补充） | Approval | Labeling | |||
| 1981/03/02 | SUPPL-74（补充） | Approval | Labeling | |||
| 1981/03/02 | SUPPL-73（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/01/07 | SUPPL-72（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1980/09/15 | SUPPL-71（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1980/07/14 | SUPPL-65（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1980/04/16 | SUPPL-63（补充） | Approval | Labeling | |||
| 1980/04/16 | SUPPL-62（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1980/04/08 | SUPPL-68（补充） | Approval | Labeling | |||
| 1980/01/22 | SUPPL-64（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/12/03 | SUPPL-61（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/12/03 | SUPPL-59（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/11/29 | SUPPL-66（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/11/27 | SUPPL-60（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/10/10 | SUPPL-67（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/07/17 | SUPPL-58（补充） | Approval | Labeling | |||
| 1979/03/27 | SUPPL-51（补充） | Approval | Labeling | |||
| 1979/03/27 | SUPPL-50（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/03/27 | SUPPL-47（补充） | Approval | Labeling | |||
| 1979/03/27 | SUPPL-46（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/02/16 | SUPPL-54（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/02/06 | SUPPL-45（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/02/01 | SUPPL-57（补充） | Approval | STANDARD | |||
| 1978/11/24 | SUPPL-48（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/11/01 | SUPPL-56（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/10/17 | SUPPL-55（补充） | Approval | Labeling | |||
| 1978/09/13 | SUPPL-34（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/09/08 | SUPPL-49（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/09/08 | SUPPL-44（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/09/08 | SUPPL-42（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/08/15 | SUPPL-43（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/08/03 | SUPPL-36（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/07/11 | SUPPL-25（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/06/26 | SUPPL-40（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/06/05 | SUPPL-38（补充） | Approval | Labeling | |||
| 1978/06/05 | SUPPL-37（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/06/05 | SUPPL-31（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/05/31 | SUPPL-33（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 1978/04/06 | SUPPL-35（补充） | Approval | Labeling | |||
| 1978/03/15 | SUPPL-19（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1978/02/17 | SUPPL-32（补充） | Approval | Labeling | |||
| 1978/02/13 | SUPPL-28（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1978/02/09 | SUPPL-18（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/02/08 | SUPPL-39（补充） | Approval | Labeling | |||
| 1978/01/23 | SUPPL-24（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/01/17 | SUPPL-53（补充） | Approval | Labeling | |||
| 1978/01/17 | SUPPL-52（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1977/09/28 | SUPPL-27（补充） | Approval | Labeling | |||
| 1977/09/28 | SUPPL-26（补充） | Approval | Labeling | |||
| 1977/09/09 | SUPPL-23（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1977/09/09 | SUPPL-22（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1977/09/09 | SUPPL-21（补充） | Approval | Labeling | |||
| 1977/09/09 | SUPPL-20（补充） | Approval | Labeling | |||
| 1977/04/29 | SUPPL-17（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1976/11/23 | SUPPL-15（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1976/11/08 | SUPPL-12（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1976/10/15 | SUPPL-16（补充） | Approval | Labeling | |||
| 1976/04/06 | SUPPL-10（补充） | Approval | Labeling | |||
| 1976/04/06 | SUPPL-9（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1976/03/01 | SUPPL-13（补充） | Approval | Labeling | |||
| 1975/11/20 | SUPPL-11（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1975/10/29 | SUPPL-7（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1975/09/03 | SUPPL-8（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1975/05/20 | SUPPL-6（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1975/05/20 | SUPPL-2（补充） | Approval | Manufacturing (CMC)-Control | STANDARD |
