FDA.reportPublic FDA data

Application 076850

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERCONAZOLETERCONAZOLESUPPOSITORY;VAGINAL80MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076850-001TERCONAZOLETERCONAZOLE80MGSUPPOSITORY / VAGINAL2006-07-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076850-001TERCONAZOLE80MGSUPPOSITORY / VAGINAL2006-07-12a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TerconazoleTERCONAZOLECosette Pharmaceuticals, Inc.38cd1718-6b3c-415d-a17f-7b399adb0ba22026-05-07Warnings, Adverse reactionsName fallback
brand name: Terconazole
generic name: TERCONAZOLE
Terconazole Vaginal Cream 0.8%TERCONAZOLEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCf59448bd-f730-46d2-a785-c2d6205579ff2026-01-28Warnings, Adverse reactionsName fallback
generic name: TERCONAZOLE
TerconazoleTERCONAZOLEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC10e84353-93d2-461d-8b79-e9294df047ae2026-01-28Warnings, Adverse reactionsName fallback
brand name: Terconazole
generic name: TERCONAZOLE
TerconazoleTERCONAZOLESun Pharmaceutical Industries, Inc.6d7a8fd6-7837-427e-9b18-89e33351b05e2025-07-07Warnings, Adverse reactionsName fallback
brand name: Terconazole
generic name: TERCONAZOLE
TerconazoleTERCONAZOLESun Pharmaceutical Industries, Inc.b4f50a11-bd39-4023-9145-2da60f6b085f2025-07-07Warnings, Adverse reactionsName fallback
brand name: Terconazole
generic name: TERCONAZOLE
TerconazoleTERCONAZOLESun Pharmaceutical Industries, Inc.2b3923b5-0a97-428c-b8d2-4a3ceb3447a12025-05-27Warnings, Adverse reactionsName fallback
brand name: Terconazole
generic name: TERCONAZOLE
TerconazoleTERCONAZOLENuCare Pharmaceuticals,Inc.71c13149-396e-edc6-e053-2a95a90af50c2024-12-24Warnings, Adverse reactionsName fallback
brand name: Terconazole
generic name: TERCONAZOLE
TerconazoleTERCONAZOLEPadagis Israel Pharmaceuticals Ltd207e9cf2-e8ec-43d7-9c11-46283c9cdb372024-09-30Warnings, Adverse reactionsName fallback
brand name: Terconazole
generic name: TERCONAZOLE
TerconazoleTERCONAZOLEA-S Medication Solutionsb922feb5-cd85-4f13-9a18-913e58f8da832023-12-09Warnings, Adverse reactionsName fallback
brand name: Terconazole
generic name: TERCONAZOLE
TerconazoleTERCONAZOLEA-S Medication Solutionse0a5e163-741f-4f5e-9d2e-b733f9879c992023-10-31Warnings, Adverse reactionsName fallback
brand name: Terconazole
generic name: TERCONAZOLE
Terconazole Vaginal Cream 0.8%TERCONAZOLEA-S Medication Solutions9b1c38ac-ebf3-471c-bcdf-1ff8ad197f912023-01-03Warnings, Adverse reactionsName fallback
generic name: TERCONAZOLE
TerconazoleTERCONAZOLEA-S Medication Solutions1e32bf0d-2a93-44ac-ae28-8d34e10380c02023-01-03Warnings, Adverse reactionsName fallback
brand name: Terconazole
generic name: TERCONAZOLE