HYALGAN(R)
FDA premarket approval P950027/S001 · decided 1997-07-08
Approval details
- PMA number
- P950027
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HYALGAN(R)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Fidia Farmaceutici S.P.A.
- Date received
- 1997-06-24
- Decision date
- 1997-07-08
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Abano Terme
- Statement
- APPROVAL FOR THE U.S. DISTRIBUTOR, SANOFI PHARMACEUTICALS, INC., NEW YORK, NEW YORK. ADDITIONALLY, WE HAVE REVIEWED THE EDITORIAL CHANGES YOU PROPOSE FOR THE LABELING FOR YOUR PRODUCT AND HAVE DETERMINED THAT THEY ARE APPROPRIATE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HyaloGYN Vaginal Moisturizing Suppositories (K191052) | Fidia Farmaceutici S.P.A. | 2020-01-09 |
| HyaloGYN Vaginal Hydrating Gel (K150883) | Fidia Farmaceutici S.P.A. | 2015-09-01 |
| HYALO GYN (K094039) | Fidia Farmaceutici S.P.A. | 2010-05-07 |