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Terconazole

Generic Name
Terconazole
Brand Names
Terazol 3
Drug Type
Small Molecule
Chemical Formula
C26H31Cl2N5O3
CAS Number
67915-31-5
Unique Ingredient Identifier
0KJ2VE664U

Overview

Terconazole is an anti-fungal drug that is mainly used to treat vaginal yeast infections (or vaginal candidiasis). It is classified as a triazole ketal derivative. Terconazole was initially approved by the FDA in 1987. This drug is available in cream and suppository forms and both have demonstrated high levels of safety, efficacy, and tolerability in clinical trials. Due to the existence of 2 stereocentres, there are 4 possible stereoisomers for terconazole.

Indication

For the treatment of candidiasis (a yeast-like fungal infection) of the vulva and vagina.

Associated Conditions

  • Vulvovaginal Candidiasis

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
H.J. Harkins Company, Inc.
52959-811
VAGINAL
4 mg in 1 g
1/19/2012
Bryant Ranch Prepack
63629-8837
VAGINAL
8 mg in 1 g
9/15/2021
A-S Medication Solutions
50090-1196
VAGINAL
8 mg in 1 g
11/7/2019
Physicians Total Care, Inc.
54868-5183
VAGINAL
8 mg in 1 g
8/30/2010
RPK Pharmaceuticals, Inc.
53002-7240
VAGINAL
8 mg in 1 g
11/7/2019
A-S Medication Solutions
50090-6266
VAGINAL
4 mg in 1 g
3/9/2021
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
0168-0346
VAGINAL
4 mg in 1 g
3/9/2021
A-S Medication Solutions
50090-0917
VAGINAL
4 mg in 1 g
11/7/2019
Cosette Pharmaceuticals, Inc.
0713-0552
VAGINAL
80 mg in 1 1
11/23/2022
A-S Medication Solutions
50090-1901
VAGINAL
8 mg in 1 g
8/20/2014

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
TERAZOL 3 VAGINAL CREAM 0.8%
01934155
Cream - Vaginal
0.8 %
12/31/1992
TERAZOL 7 VAGINAL CREAM 0.4%
00894729
Cream - Vaginal
4 MG / G
12/31/1991
TERAZOL 3 VAGINAL OVULES 80MG
00894710
Ovule - Vaginal
80 MG
12/31/1991
TERAZOL 3 DUAL PAK
02130874
Cream ,  Ovule ,  Kit - Vaginal
0.8 %
12/31/1994
TERAZOL 3 DUAL PAK
02130874
Cream ,  Ovule ,  Kit - Vaginal
80 MG
12/31/1994
TARO-TERCONAZOLE
02247651
Cream - Vaginal
0.4 %
9/21/2004

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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