MedPath

Fluocinonide

Generic Name
Fluocinonide
Brand Names
Lidemol, Lidex, Lyderm, Tiamol, Vanos
Drug Type
Small Molecule
Chemical Formula
C26H32F2O7
CAS Number
356-12-7
Unique Ingredient Identifier
2W4A77YPAN

Overview

A topical glucocorticoid used in the treatment of eczema.

Indication

A topical anti-inflammatory product for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Associated Conditions

  • Dermatosis
  • Inflammation
  • Pruritus

Clinical Trials

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Teligent Pharma, Inc.
52565-040
TOPICAL
0.5 mg in 1 g
8/12/2016
IPG PHARMACEUTICALS, INC.
71085-005
TOPICAL
0.5 mg in 1 g
2/15/2017
A-S Medication Solutions
50090-2419
TOPICAL
0.5 mg in 1 g
12/6/2022
Aidarex Pharmaceuticals LLC
33261-560
TOPICAL
0.5 mg in 1 g
8/23/2018
Asclemed USA, Inc.
76420-509
TOPICAL
1 mg in 1 g
12/16/2023
NuCare Pharmaceuticals,Inc.
68071-1754
TOPICAL
0.5 mg in 1 g
2/11/2021
NuCare Pharmaceuticals, Inc.
66267-973
TOPICAL
0.5 mg in 1 g
1/11/2021
NuCare Pharmaceuticals,Inc.
68071-4921
TOPICAL
0.5 mg in 1 g
2/18/2021
Preferred Pharmaceuticals Inc.
68788-8105
TOPICAL
0.5 mg in 1 g
6/8/2023
NuCare Pharmaceuticals,Inc.
68071-2808
TOPICAL
0.5 mg in 1 g
8/8/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
LIDEMOL 0.05%
syntex inc.
00424943
Cream ,  Emulsion - Topical
.05 %
12/31/1979
LYDERM
taropharma, a division of taro pharmaceuticals inc.
00716863
Cream - Topical
0.05 % / W/W
12/31/1988
LYDONIDE EMOLLIENT CREAM 0.05%
technilab pharma inc.
02187671
Cream - Topical
.05 %
7/30/1996
LIDEMOL
bausch health, canada inc.
02163152
Cream - Topical
0.05 % / W/W
12/31/1995
LIDEX OINTMENT MILD 0.01%
medicis canada ltd.
00274445
Ointment - Topical
0.01 %
12/31/1973
TOPSYN 0.05%
syntex inc.
00281913
Jelly - Topical
.5 MG / G
12/31/1973
LIDEX CREAM MILD 0.01%
medicis canada ltd.
00274453
Cream - Topical
0.01 %
12/31/1972
LIDEX ONT 0.05%
syntex inc.
00274437
Ointment - Topical
.05 %
12/31/1973
LIDEX
bausch health, canada inc.
02161923
Cream - Topical
0.05 % / W/W
12/31/1996
LYDERM
taropharma, a division of taro pharmaceuticals inc.
02236996
Ointment - Topical
0.05 %
10/15/1999

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
NOVOTER 0,5 MG/G CREMA
Teofarma S.R.L.
54036
CREMA
Medicamento Sujeto A Prescripción Médica
Commercialized
ABRASONE RECTAL, CREMA RECTAL
Anotaciones Farmaceuticas, S.L.
56385
CREMA RECTAL
Sin Receta
Commercialized
NOVOTER GENTAMICINA 0,5 MG/G + 1 MG/G CREMA
Teofarma S.R.L.
54003
CREMA
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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