FDA.reportPublic FDA data

Application 218499

Type
ANDA
Sponsor
NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FINASTERIDE AND TADALAFILFINASTERIDE; TADALAFILCAPSULE;ORAL5MG;5MGNoNo

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
A218499-001FINASTERIDE AND TADALAFILFINASTERIDE; TADALAFIL5MG;5MGCAPSULE / ORAL2025-03-19

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
2026-02-19 14:30 UTC2026-02A218499-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORAL2025-03-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218499-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORAL2025-03-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A218499-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORAL2025-03-196a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218499-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORAL2025-03-19a50c72e98297…