FDA.reportPublic FDA data

Application 217190

Type
ANDA
Sponsor
SUN PHARMA CANADA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HALOBETASOL PROPIONATE AND TAZAROTENEHALOBETASOL PROPIONATE; TAZAROTENELOTION;TOPICAL0.01%;0.045%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
A217190-001HALOBETASOL PROPIONATE AND TAZAROTENEHALOBETASOL PROPIONATE; TAZAROTENE0.01%;0.045%LOTION / TOPICALAB2025-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217190-001AB

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
2026-02-19 14:30 UTC2026-02A217190-001HALOBETASOL PROPIONATE AND TAZAROTENE0.01%;0.045%LOTION / TOPICALAB2025-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217190-001HALOBETASOL PROPIONATE AND TAZAROTENE0.01%;0.045%LOTION / TOPICALAB2025-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A217190-001HALOBETASOL PROPIONATE AND TAZAROTENE0.01%;0.045%LOTION / TOPICALAB2025-05-026a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217190-001HALOBETASOL PROPIONATE AND TAZAROTENE0.01%;0.045%LOTION / TOPICALAB2025-05-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217190-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217190-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217190-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217190-001AB1a50c72e98297…