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RESTYLANEP020023

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RESTYLANE is a Hyaluronic acid filler product, registered by Q-Med AB. Linked registrations: US P020023. First approved in US on 2003-12-12 (P020023). 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

Product
Regulatory class
Not determined (no verified registration linked)Could not verify
Category
Hyaluronic acid filler
US · FDA PMA
P020023
Name on registration
RESTYLANE INJECTABLE GEL
Registrant
Q-Med AB
First approval
2003-12-12
This certificate issued
2003-12-12
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

    P020023 first approved

  2. US

    P020023 · P020023/S007

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜CHANGE IN THE CLEANING PROCESS.

  3. US

    P020023 · P020023/S008

    Special (Immediate Track)｜Labeling Change - Indications/instructions/shelf life/tradename｜APPROVAL FOR THE PRODUCT BOX LABEL TO SAY "SYRINGE…

  4. US

    P020023 · P020023/S009

    Real-Time Process｜Labeling Change - Indications/instructions/shelf life/tradename｜APPROVAL FOR INCREASING THE EXPIRATION DATING FOR RESTYLAN…

  5. US

    P020023 · P020023/S010

    30-Day Notice｜CHANGE OF LOCATION FOR A MANUFACTURING PROCESS.

  6. US

    P020023 · P020023/S011

    Special (Immediate Track)｜Labeling Change - Indications/instructions/shelf life/tradename｜APPROVAL FOR CHANGES IN PRODUCT LABELING.

  7. US

    P020023 · P020023/S012

    135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜APPROVAL FOR PERFORMING THE PROTEIN TESTING IN…

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
  • P020023: 135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Pack…2005-10-21
  • P020023: Special (Immediate Track)｜Labeling Change - Indications/instructions/shelf life/…2005-03-11
  • P020023: 30-Day Notice｜CHANGE OF LOCATION FOR A MANUFACTURING PROCESS.2004-09-17
  • P020023: Real-Time Process｜Labeling Change - Indications/instructions/shelf life/tradenam…2004-08-06
  • P020023: Special (Immediate Track)｜Labeling Change - Indications/instructions/shelf life/…2004-07-23

Sources

1