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Restylane Injectable GelP040024

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Restylane Injectable Gel is a Hyaluronic acid filler product, registered by Q-Med AB. Linked registrations: US P040024. First approved in US on 2005-03-25 (P040024). Data as of 2026-10-19.

  • Regulatory classHyaluronic acid filler · class not determined
  • HolderQ-Med AB
  • JurisdictionsUS
  • Updated2026-10-19 · v1

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

Registration and basics

Restylane Injectable Gel

Product
Regulatory class
Not determined (no verified registration linked)Could not verify
Category
Hyaluronic acid filler
US · FDA PMA
P040024
Name on registration
RESTYLANE INJECTABLE GEL
Registrant
Q-Med AB
First approval
2005-03-25
This certificate issued
2005-03-25
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

    P040024 first approved

  2. US

    P040024 · P040024/S144

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜approval for modifications to the Water for Injection (WFI) system

  3. US

    P040024 · P040024/S142

    Panel Track｜Labeling Change - Indications/instructions/shelf life/tradename｜Approval for Restylane® Lyft with Lidocaine for subcutaneous and…

  4. US

    P040024 · P040024/S146

    Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜Approval for the postapproval study (PAS) protocol submitted to comply with the…

  5. US

    P040024 · P040024/S143

    Normal 180 Day Track｜Change Design/Components/Specifications/Material｜multiple changes including, (1) primary packaging, (2) a new needle an…

  6. US

    P040024 · P040024/S147

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜changes to the particle size reduction process for Restylane Lyft w…

  7. US

    P040024 · P040024/S148

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜changes in analytical test methods used in the quality control test…

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.

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Recent changes

5
  • P040024: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜changes…2026-03-12
  • P040024: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜changes…2026-02-05
  • P040024: Normal 180 Day Track｜Change Design/Components/Specifications/Material｜multiple c…2026-01-29
  • P040024: Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜Approval for the po…2025-12-23
  • P040024: Panel Track｜Labeling Change - Indications/instructions/shelf life/tradename｜Appr…2025-11-04

Sources

1