FDA.reportPublic FDA data

Application 218232

Type
ANDA
Sponsor
ZYDUS LIFESCIENCES

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
A218232-001FINASTERIDE AND TADALAFILFINASTERIDE; TADALAFIL5MG;5MGCAPSULE / ORAL2024-03-15

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 UTC2026-02A218232-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORAL2024-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218232-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORAL2024-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A218232-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORAL2024-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218232-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORAL2024-03-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218232-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORAL2024-03-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218232-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORAL2024-03-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218232-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORAL2024-03-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218232-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORALAB2024-03-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218232-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORAL2024-03-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218232-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORAL2024-03-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218232-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORALAB2024-03-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218232-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORALAB2024-03-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218232-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORALAB2024-03-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218232-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORALAB2024-03-158072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218232-001FINASTERIDE AND TADALAFIL5MG;5MGCAPSULE / ORAL2024-03-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218232-001AB15bbf6a4d5a75…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218232-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218232-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218232-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218232-001AB18072bd15b7f6…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78274ORIG 2024-04-26