FDA.reportPublic FDA data

Application 076712

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERCONAZOLETERCONAZOLECREAM;VAGINAL0.4%NoNo

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
A076712-001TERCONAZOLETERCONAZOLE0.4%CREAM / VAGINALAB2005-02-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076712-001AB

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 22:54:322026-06A076712-001TERCONAZOLE0.4%CREAM / VAGINALAB2005-02-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076712-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TerconazoleTERCONAZOLEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC10e84353-93d2-461d-8b79-e9294df047ae2026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076712
application number: ANDA076712
ndc (product): 0168-0346
TerconazoleTERCONAZOLEA-S Medication Solutionse0a5e163-741f-4f5e-9d2e-b733f9879c992023-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076712
application number: ANDA076712
ndc (product): 50090-6266

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0346TerconazoleterconazoleE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0346TerconazoleterconazoleE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0346TerconazoleterconazoleE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0346TerconazoleterconazoleE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
50090-6266TerconazoleterconazoleA-S Medication SolutionsANDACurrent