FDA.reportPublic FDA data

Application 086576

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TYZINETETRAHYDROZOLINE HYDROCHLORIDESOLUTION;NASAL0.1%NoNo
002TYZINETETRAHYDROZOLINE HYDROCHLORIDESOLUTION;NASAL0.05%NoYes
003TYZINETETRAHYDROZOLINE HYDROCHLORIDESPRAY;NASAL0.1%NoYes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A086576-001TYZINETETRAHYDROZOLINE HYDROCHLORIDE0.1%SOLUTION / NASALApproved before 1982
A086576-002TYZINETETRAHYDROZOLINE HYDROCHLORIDE0.05%SOLUTION / NASALRS, Approved before 1982
A086576-003TYZINETETRAHYDROZOLINE HYDROCHLORIDE0.1%SPRAY / NASALRS, Approved before 1982

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 22:54:322026-06A086576-001TYZINE0.1%SOLUTION / NASALApproved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A086576-002TYZINE0.05%SOLUTION / NASALRS, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A086576-003TYZINE0.1%SPRAY / NASALRS, Approved before 1982a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medics Choice Eye Drops Original Redness RelieverTETRAHYDROZOLINE HYDROCHLORIDEKC Pharmaceuticals, Inc.e42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be2025-12-30WarningsName fallback
generic name: TETRAHYDROZOLINE HYDROCHLORIDE
Lil Drug Store Eye Drops Redness RelieverTETRAHYDROZOLINE HYDROCHLORIDELil Drug Store Products, Incd2a47e98-a04c-47ec-aded-d1c894f040e22024-12-30WarningsName fallback
generic name: TETRAHYDROZOLINE HYDROCHLORIDE
Visine Red Eye ComfortTETRAHYDROZOLINE HYDROCHLORIDEKenvue Brands LLCd7abd7cb-e094-481f-bea5-a5983e2c9ef42024-11-13WarningsName fallback
generic name: TETRAHYDROZOLINE HYDROCHLORIDE