EUFLEXXA (1% SODIUM HYALURONATE)
FDA premarket approval P010029/S010 · decided 2010-10-25
Approval details
- PMA number
- P010029
- Supplement
- S010
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EUFLEXXA (1% SODIUM HYALURONATE)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ferring Pharmaceuticals, Inc.
- Date received
- 2009-11-17
- Decision date
- 2010-10-25
- Days to decision
- 342 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR ADDITION OF NEW EQUIPMENT USED IN THE MANUFACTURING PROCESS TO INCREASE FINISHED PRODUCT LOT CAPACITY 3 ¿ 4 FOLD.
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