FDA.reportPublic FDA data

FIDIA FARMACEUTICI SPA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96102003002806986FIDIA FARMACEUTICI SPA1N2026-01-01VIA PONTE DELLA FABBRICA 3/A ABANO TERME Padova IT 35031

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M7131797040Hyalo GYN Vaginal Hydrating Gel - Made without Parabens - HYALO GYN® Vaginal Hydrating Gel, 30g Tube - Made without Parabens is a personal lubricant for vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with polyisoprene condoms.973-577-6202regulatory@fidiapharma.us
M7133797040Hyalo GYN Vaginal Hydrating Gel - Made without Parabens Sample - HYALO GYN® Vaginal Hydrating Gel, 10g Tube - Made without Parabens Sample is a personal lubricant for vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with polyisoprene condoms.973-577-6202regulatory@fidiapharma.us
M713891220750010HYMOVIS® ONE 32mg/4ml syringe - HYMOVIS® ONE Viscoelastic Hyaluronan is an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® ONE is derived from bacterial fermentation. HYMOVIS® ONE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in single injection regimen. The product is packaged in a one syringe pack.9735776202compliance@fidiapharma.us

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
165681460383145P950027HYALGAN(R)MOZ1997-05-28
165681159509043P180040TRILURONMOZ2019-03-26
165682061786088P150010HYMOVISMOZ2015-08-28
165681219753642K984267MODIFICATION OF BIONECT HYDROGEL FOAMMGQ1999-02-10
165681737879289K973725BIONECT CLEAR HYDROGELMGQ1998-09-22
165681233449017K973724BIONECT HYDROGEL SPRAYMGQ1998-09-22
165681439360072K973722BIONECT HYDROGEL FOAMMGQ1998-09-22
165681454915014K963004BIONECT CREAMMGQ1997-02-12
165681545377465K191052HyaloGYN Vaginal Moisturizing SuppositoriesNUC2020-01-09
165681240308206K150883HyaloGYN Vaginal Hydrating GelNUC2015-09-01
165681433811887K094039HYALO GYNNUC2010-05-07
165681468367281BK180296

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MGQ71999-02-10
NUC32020-01-09
MOZ32019-03-26

PMA#

HYALGAN® (sodium hyaluronate)

2023-01-19

FIDIA FARMACEUTICI SPAvia Ponte Della Fabbrica 3/aabano Terme, Padua (pd) 35031 PMA NumberP950027 Supplement NumberS018 Date Received12/23/2022 Decision Date01/19/2023 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement R...

HYALGAN®

2022-10-04

FIDIA FARMACEUTICI SPAvia Ponte Della Fabbrica 3/aabano Terme, Padua (pd) 35031 PMA NumberP950027 Supplement NumberS017 Date Received09/08/2022 Decision Date10/04/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement R...

HYALGAN®

2022-08-08

FIDIA FARMACEUTICI SPAvia Ponte Della Fabbrica 3/aabano Terme, Padua (pd) 35031 PMA NumberP950027 Supplement NumberS016 Date Received07/11/2022 Decision Date08/08/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement R...

HYALGAN

2016-08-26

FIDIA FARMACEUTICI SPA

HYALGAN

2013-09-26

FIDIA FARMACEUTICI SPA

HYALGAN

2010-03-28

FIDIA FARMACEUTICI SPA

HYALGAN

2008-05-23

FIDIA FARMACEUTICI SPA

HYALGAN

2008-05-01

FIDIA FARMACEUTICI SPA

HYALGAN

2008-01-08

FIDIA FARMACEUTICI SPA

HYALGAN

2005-07-19

FIDIA FARMACEUTICI SPA

HYALGAN

2000-08-30

FIDIA FARMACEUTICI SPA

PMN#

GUDID#

HYMOVIS® ONE 32mg/4ml syringe - HYMOVIS® ONE Viscoelastic Hyaluronan is an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® ONE is derived from bacterial fermentation. HYMOVIS® ONE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in single injection regimen. The product is packaged in a one syringe pack.

FIDIA FARMACEUTICI SPA

2025-11-07

HYMOVIS® ONE Professional Sample, 32mg/4ml syringe - HYMOVIS® ONE Viscoelastic Hyaluronan is an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® ONE is derived from bacterial fermentation. HYMOVIS® ONE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in single injection regimen. The product is packaged in a one syringe pack.

FIDIA FARMACEUTICI SPA

2025-11-07

COL-FID4 Care Collagen Wound Dressing - COL-FID 4 CARE Collagen is a native 100% Bovine Type 1 collagen, which when applied to a wound surface, absorbs wound exudate, and maintains a moist wound environment to aid in the management of wound healing. COL-FID 4 Care Collagen Dressing may be used in the management of partial and full thickness wounds,pressure (stage I-IV) and venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis and diabetic ulcers, cuts, and abrasions. Each carton contains 5 dressings and each case contains 10 cartons.

FIDIA FARMACEUTICI SPA

2025-11-24

Hyalgan® Sodium Hyaluronate 2mL Vial - Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL vial is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.

FIDIA FARMACEUTICI SPA

2015-07-31

Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL - Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.

FIDIA FARMACEUTICI SPA

2015-07-31

Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL - Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles.

FIDIA FARMACEUTICI SPA

2023-10-16

Hyalgan® Sodium Hyaluronate 2mL Vial - Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL vial is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.

FIDIA FARMACEUTICI SPA

2023-09-13

Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe - HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals.

FIDIA FARMACEUTICI SPA

2016-03-21

HYALO GYN Vaginal Moisturizing Suppositories Sample - HyaloGYN Vaginal Moisturizing Suppositories are personal lubricants, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The suppositories are made without parabens. The sample box contains 3 suppositories

FIDIA FARMACEUTICI SPA

2021-03-25

Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe, 1 pack - HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals. The product is packaged in a one syringe pack.

FIDIA FARMACEUTICI SPA

2022-09-26

vH Essentials Moisturizing Vaginal Suppositories - vH Essentials Moisturizing Vaginal Suppositories are a non-hormonal moisturizer delivered in an easy-to-use suppository format. vH Essentials Moisturizing Vaginal Suppositories, intended for the temporary relief of vaginal dryness symptoms, moisturize and lubricate the vaginal epithelium to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is not compatible with natural rubber latex, polyurethane and polyisoprene condoms.

FIDIA FARMACEUTICI SPA

2022-09-15

CVS Health Moisturizing Vaginal Suppositories - CVS Health™ Moisturizing Vaginal Suppositories are a non-hormonal moisturizer delivered in an easy-to-use suppository format. CVS Health™ Moisturizing Vaginal Suppositories, intended for the temporary relief of vaginal dryness symptoms, moisturize and lubricate the vaginal epithelium to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is not compatible with natural rubber latex, polyurethane and polyisoprene condoms.

FIDIA FARMACEUTICI SPA

2022-09-15

Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe - HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals.

FIDIA FARMACEUTICI SPA

2017-02-12

HYALO GYN Vaginal Moisturizing Suppositories - HyaloGYN Vaginal Moisturizing Suppositories are personal lubricants, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The suppositories are made without parabens. Packaged as a box of 10 suppositories.

FIDIA FARMACEUTICI SPA

2021-03-25

Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe - HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).

FIDIA FARMACEUTICI SPA

2015-11-06

Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe - HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).

FIDIA FARMACEUTICI SPA

2017-02-12