Medcxy

Product dossierBuilt from registrations, label text and platform-curated data

HYDRELLEP050033

Ask about this product

HYDRELLE is a Hyaluronic acid filler product, registered by Anika Therapeutics, Inc.. Linked registrations: US P050033. First approved in US on 2006-12-20 (P050033). Data as of 2026-10-19.

  • Regulatory classHyaluronic acid filler · class not determined
  • HolderAnika Therapeutics, Inc.
  • JurisdictionsUS
  • Updated2026-10-19 · v1

Registration and basics are public; findings and prices need an account

Registration and basics

HYDRELLE

Product
Regulatory class
Not determined (no verified registration linked)Could not verify
Category
Hyaluronic acid filler
US · FDA PMA
P050033 (cancelled)
Registrant
Anika Therapeutics, Inc.
First approval
2006-12-20
This certificate issued
2006-12-20
Checked against official page
Not yet checked field by field against the live official page

Public: fields from the registration record.

Label facts by jurisdiction

What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A

No data yet

Registration timeline

  1. US

    P050033 first approved

  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…

First approval, this certificate's issue date (updated after renewals or changes), changes and expiry are listed separately; a missing first approval means it was not obtained from an official source. Up to 6 recent changes per registration; click the number for the full record.

Cross findings · Price observations

Sign in to see findings and prices

Findings and prices stay out of indexable pages.

Sign in to view

Recent changes

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

Sources

1