EUFLEXXA
FDA premarket approval P010029/S038 · decided 2024-04-06
Approval details
- PMA number
- P010029
- Supplement
- S038
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EUFLEXXA
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ferring Pharmaceuticals, Inc.
- Date received
- 2024-03-07
- Decision date
- 2024-04-06
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for updating the syringe label to include the symbol for a single barrier system with protective packaging outside.
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