EUFLEXXA
FDA premarket approval P010029/S021 · decided 2015-01-21
Approval details
- PMA number
- P010029
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EUFLEXXA
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ferring Pharmaceuticals, Inc.
- Date received
- 2014-12-24
- Decision date
- 2015-01-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- PROPOSED REVISED STABILITY PROTOCOL.
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