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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 001 | INFED | IRON DEXTRAN | INJECTABLE;INJECTION | EQ 100MG IRON/2ML (EQ 50MG IRON/ML) | Yes | Yes | BP | 1974/04/29 | 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 |
|---|---|---|---|---|---|---|
| 1974/04/29 | ORIG-1（原始申请） | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
>>>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 |
|---|---|---|---|---|---|---|
| 2024/08/01 | SUPPL-181（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2021/09/14 | SUPPL-180（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2021/04/20 | SUPPL-179（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2020/09/11 | SUPPL-178（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2009/08/12 | SUPPL-171（补充） | Approval | Labeling | STANDARD | ||
| 2002/11/26 | SUPPL-164（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 2001/11/20 | SUPPL-162（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 2001/07/24 | SUPPL-160（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 2001/07/23 | SUPPL-159（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 2001/04/18 | SUPPL-161（补充） | Approval | Labeling | STANDARD | ||
| 1999/09/13 | SUPPL-158（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1999/04/15 | SUPPL-157（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1999/01/13 | SUPPL-155（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1999/01/13 | SUPPL-154（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1998/05/22 | SUPPL-153（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1997/04/04 | SUPPL-151（补充） | Approval | Labeling | STANDARD | ||
| 1997/04/04 | SUPPL-150（补充） | Approval | Labeling | STANDARD | ||
| 1997/02/21 | SUPPL-152（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1995/08/11 | SUPPL-149（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1994/04/13 | SUPPL-148（补充） | Approval | Labeling | STANDARD | ||
| 1994/04/12 | SUPPL-146（补充） | Approval | Manufacturing (CMC)-Packaging | PRIORITY | ||
| 1992/04/22 | SUPPL-145（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1991/08/05 | SUPPL-144（补充） | Approval | Labeling | |||
| 1991/07/12 | SUPPL-143（补充） | Approval | Labeling | |||
| 1991/07/12 | SUPPL-142（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1991/07/12 | SUPPL-141（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1988/01/12 | SUPPL-139（补充） | Approval | Labeling | |||
| 1986/04/07 | SUPPL-138（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1985/05/13 | SUPPL-137（补充） | Approval | Labeling | |||
| 1981/06/17 | SUPPL-135（补充） | Approval | Labeling | |||
| 1981/06/15 | SUPPL-134（补充） | Approval | Labeling | |||
| 1981/06/15 | SUPPL-133（补充） | Approval | Labeling | |||
| 1981/06/15 | SUPPL-132（补充） | Approval | Labeling | |||
| 1981/03/05 | SUPPL-130（补充） | Approval | Labeling | |||
| 1981/03/05 | SUPPL-129（补充） | Approval | Labeling | |||
| 1981/02/18 | SUPPL-131（补充） | Approval | Labeling | |||
| 1981/02/03 | SUPPL-128（补充） | Approval | Labeling | |||
| 1981/01/16 | SUPPL-127（补充） | Approval | Labeling | |||
| 1980/08/20 | SUPPL-126（补充） | Approval | Labeling | |||
| 1980/08/20 | SUPPL-125（补充） | Approval | Labeling | |||
| 1980/07/07 | SUPPL-121（补充） | Approval | Labeling | |||
| 1980/04/01 | SUPPL-120（补充） | Approval | Labeling | |||
| 1980/01/21 | SUPPL-119（补充） | Approval | Labeling | |||
| 1980/01/21 | SUPPL-118（补充） | Approval | Labeling | |||
| 1980/01/21 | SUPPL-117（补充） | Approval | Labeling | |||
| 1980/01/21 | SUPPL-116（补充） | Approval | Labeling | |||
| 1980/01/21 | SUPPL-115（补充） | Approval | Labeling | |||
| 1980/01/21 | SUPPL-114（补充） | Approval | Labeling | |||
| 1980/01/21 | SUPPL-113（补充） | Approval | Labeling | |||
| 1979/08/13 | SUPPL-111（补充） | Approval | Labeling | |||
| 1979/08/13 | SUPPL-110（补充） | Approval | Labeling | |||
| 1979/08/13 | SUPPL-109（补充） | Approval | Labeling | |||
| 1979/08/13 | SUPPL-108（补充） | Approval | Labeling | |||
| 1979/08/13 | SUPPL-107（补充） | Approval | Labeling | |||
| 1979/08/13 | SUPPL-106（补充） | Approval | Labeling | |||
| 1979/08/13 | SUPPL-105（补充） | Approval | Labeling | |||
| 1978/08/07 | SUPPL-104（补充） | Approval | Labeling | |||
| 1978/07/31 | SUPPL-103（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-102（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-101（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-100（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-99（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-98（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-97（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-96（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-95（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-94（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-93（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-92（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-91（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-90（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-89（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-88（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-87（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-86（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-85（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-84（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-83（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-82（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-81（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-80（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-79（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-78（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-77（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-76（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-75（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-74（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-73（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-72（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-71（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-70（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-69（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-68（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-67（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-66（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-65（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-64（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-63（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-62（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-61（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/07/31 | SUPPL-60（补充） | Approval | Labeling | |||
| 1978/07/31 | SUPPL-59（补充） | Approval | Labeling | |||
| 1978/07/31 | SUPPL-58（补充） | Approval | Labeling | |||
| 1978/07/31 | SUPPL-57（补充） | Approval | Labeling | |||
| 1978/07/31 | SUPPL-56（补充） | Approval | Labeling | |||
| 1978/07/31 | SUPPL-27（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-54（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-53（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-52（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-51（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-50（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-48（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-47（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-46（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-43（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-42（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-41（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-40（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-39（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-38（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-37（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-36（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-35（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-34（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-33（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-32（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-31（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-30（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-29（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-28（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-26（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-25（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-23（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-22（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-21（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-20（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-19（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-18（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-17（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-16（补充） | Approval | Labeling | |||
| 1976/10/04 | SUPPL-15（补充） | Approval | Labeling | |||
| 1976/01/22 | SUPPL-45（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1975/03/26 | SUPPL-13（补充） | Approval | Labeling | |||
| 1975/03/26 | SUPPL-12（补充） | Approval | Labeling | |||
| 1975/03/26 | SUPPL-11（补充） | Approval | Labeling |
