SYNVISC (HYLAN G-F 20)
FDA premarket approval P940015/S003 · decided 1999-12-20
Approval details
- PMA number
- P940015
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SYNVISC (HYLAN G-F 20)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 1999-04-07
- Decision date
- 1999-12-20
- Days to decision
- 257 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- Approval for a labeling change in the Physician Package Insert to reflect information in the Patient Package Insert regarding the time of maximum treatment effect.
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