产品档案由注册证、说明书原文与平台整理数据生成

HYDRELLEP050033

HYDRELLE是一款玻尿酸填充产品,注册人 Anika Therapeutics, Inc.。库里关联的注册证:美国 P050033。美国首次批准于 2006-12-20(P050033)。数据截至 2026-10-19。

  • 监管属性玻尿酸填充 · 监管属性未定
  • 注册人Anika Therapeutics, Inc.
  • 辖区US
  • 档案更新于2026-10-19 · v1

注册与基本资料公开可看;交叉发现与价格需要登录

注册与基本资料

HYDRELLE

产品
监管属性
未定(还没有核实过的注册证关联)未能核实
品类
玻尿酸填充
美国 · FDA PMA
P050033(已注销)
注册人
Anika Therapeutics, Inc.
首次批准
2006-12-20
本证核发
2006-12-20
官网核对
还没有与官网现页逐字段核对

公开信息:注册证原文字段。

说明书对照(分辖区)

同一属性在不同辖区说明书里的原文;没写的标「原文未报告」,不适用的标「不适用」

暂无数据

注册时间线

  1. US

    P050033 首次批准

  2. US

    P050033 · P050033/S015

    135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|APPROVAL FOR A CHANGE IN THE SAMPLE PREPARATIO…

  3. US

    P050033 · P050033/S017

    30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|TRANSFER OF RESIDUAL SOLVENT RELEASE TESTING FROM S&N LABORATORIES …

  4. US

    P050033 · P050033/S016

    Real-Time Process|Change Design/Components/Specifications/Material|APPROVAL FOR CHANGES TO THE STABILITY PROTOCOL.

  5. US

    P050033 · P050033/S019

    30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|ACCEPTANCE OF A CHANGE TO SAMPLING FOR A TEST METHOD.

  6. US

    P050033 · P050033/S020

    Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|APPROVAL FOR LABELING MODIFICATIONS, AS REQUESTED …

  7. US

    P050033 · P050033/S018

    135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|APPROVAL OF AN ALTERNATE SUPPLIER OF A MATERIA…

分开写首次批准、本证核发(延续或变更后会更新)、变更与有效期;首次批准为空表示未从官方来源取到。每张证只列最近 6 条变更,完整记录点编号看注册证原文。

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最近变化

5
  • P050033:135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Pack…2015-11-03
  • P050033:Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/…2015-10-22
  • P050033:30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|ACCEPTA…2015-04-10
  • P050033:Real-Time Process|Change Design/Components/Specifications/Material|APPROVAL FOR …2014-07-17
  • P050033:30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|TRANSFE…2014-05-22

资料

1