MedPath

Ciclopirox Olamine

Generic Name
Ciclopirox Olamine

Overview

No overview information available.

Indication

外用于治疗由皮肤癣菌如红色毛癣菌、须癣毛癣菌。絮状表皮癣菌和犬小孢子菌等所致的浅表皮肤真菌感染,如手癣、足癣(尤其是角化增厚型)、体癣、股癣;亦可用于头癣;也适用于治疗甲真菌病。外用于由念珠菌如白色念珠菌等所致的皮肤念珠菌感染和念珠菌性外阴阴道炎。外用于由马拉色菌属所致的花斑癣。

Associated Conditions

No associated conditions information available.

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
0168-0314
TOPICAL
7.7 mg in 1 mL
8/15/2014
Bryant Ranch Prepack
63629-8624
TOPICAL
7.7 mg in 1 g
7/17/2023
Bryant Ranch Prepack
63629-8626
TOPICAL
7.7 mg in 1 g
7/17/2023
Bryant Ranch Prepack
72162-1397
TOPICAL
7.7 mg in 1 g
3/12/2024
Leading Pharma, LLC
69315-309
TOPICAL
7.7 mg in 1 mL
4/30/2020
Glenmark Pharmaceuticals Inc., USA
68462-297
TOPICAL
7.7 mg in 1 g
8/31/2019
Dispensing Solutions, Inc.
68258-3996
TOPICAL
7.7 mg in 1 g
2/14/2012
Advanced Rx Pharmacy of Tennessee, LLC
80425-0225
TOPICAL
7.7 mg in 1 g
1/9/2023
Bryant Ranch Prepack
63629-8625
TOPICAL
7.7 mg in 1 g
7/17/2023
Physicians Total Care, Inc.
54868-5270
TOPICAL
7.7 mg in 1 g
2/19/2013

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
LOPROX CREAM 1%
hoechst roussel canada inc.
01987569
Cream - Topical
10 MG / G
12/31/1994
LOPROX
bausch health, canada inc.
02221802
Cream - Topical
1 % / W/W
12/3/1996
LOPROX LOTION 1.0%
hoechst roussel canada inc.
01989626
Lotion - Topical
1 %
12/31/1995
LOPROX LOTION 1%
hoechst canada inc.
00836281
Lotion - Topical
10 MG / G
12/31/1990
LOPROX CRM 1%
hoechst canada inc.
00593362
Cream - Topical
10 MG / G
12/31/1985
LOPROX
bausch health, canada inc.
02221810
Lotion - Topical
1 % / W/W
3/24/1997
STIEPROX SHAMPOO
02247228
Shampoo - Topical
1.5 %
11/17/2003

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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