Active substance
Terconazole
- US FDA 10
- Health Canada 1
- US price lines 3
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| TERCONAZOLE | 0.8% | cream · vaginal | SUN PHARMA CANADA | Prescription | 6 Apr 2004 |
| TERCONAZOLE | 0.8% | cream · vaginal | FOUGERA | Prescription | 1 Oct 2004 |
| TERCONAZOLE | 0.4% | cream · vaginal | SUN PHARMA CANADA | Prescription | 19 Jan 2005 |
| TERCONAZOLE | 0.4% | cream · vaginal | FOUGERA PHARMS | Prescription | 18 Feb 2005 |
| TERCONAZOLE | 80MG | suppository · vaginal | PADAGIS ISRAEL | Prescription | 17 Mar 2006 |
| TERCONAZOLE | 80MG | suppository · vaginal | SUN PHARMA CANADA | Prescription | 9 Mar 2007 |
| TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | cream · vaginal | JANSSEN PHARMS | Discontinued | 31 Dec 1987 |
| TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | suppository · vaginal | JANSSEN PHARMS | Discontinued | 24 May 1988 |
| TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | cream · vaginal | JANSSEN PHARMS | Discontinued | 21 Feb 1991 |
| TERCONAZOLE | 80MG | suppository · vaginal | FOUGERA PHARMS | Discontinued | 12 Jul 2006 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| TARO-TERCONAZOLE | 02247651 | 0.4 % | CREAM · VAGINAL | TARO PHARMACEUTICALS INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | TERCONAZOLE 0.4% CREAM | $0.5523 | per GM | 23 Sep 2026 |
| US NADAC | TERCONAZOLE 0.8% CREAM | $0.98654 | per GM | 23 Sep 2026 |
| US NADAC | TERCONAZOLE 80 MG SUPPOSITORY | $18.62247 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 22 Aug 2025 TERCONAZOLE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.