FDA.reportPublic FDA data

Application 218846

Type
ANDA
Sponsor
LUPIN LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002PITOLISANTPITOLISANTTABLET17.8MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218846-001PITOLISANT HYDROCHLORIDEPITOLISANT HYDROCHLORIDEEQ 4.45MG BASETABLET / ORALAB2026-08-14
A218846-002PITOLISANT HYDROCHLORIDEPITOLISANT HYDROCHLORIDEEQ 17.8MG BASETABLET / ORALAB2026-08-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A218846-001AB
A218846-002AB

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
2026-09-14 22:38:342026-08A218846-001PITOLISANT HYDROCHLORIDEEQ 4.45MG BASETABLET / ORALAB2026-08-1484e616aacf4f…
2026-09-14 22:38:342026-08A218846-002PITOLISANT HYDROCHLORIDEEQ 17.8MG BASETABLET / ORALAB2026-08-1484e616aacf4f…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218846-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A218846-002AB184e616aacf4f…