EUFLEXXA 1% SODIUM HYALURONATE
FDA premarket approval P010029/S006 · decided 2007-07-11
Approval details
- PMA number
- P010029
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EUFLEXXA 1% SODIUM HYALURONATE
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ferring Pharmaceuticals, Inc.
- Date received
- 2007-03-22
- Decision date
- 2007-07-11
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR A SYRINGE TIP CAP MATERIAL CHANGE FROM NATURAL RUBBER TO A SYNTHETIC RUBBER FORMULATION.
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