FDA.reportPublic FDA data

Application 218764

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JASCAYDNERANDOMILASTTABLET;ORAL9MGYesNo
002JASCAYDNERANDOMILASTTABLET;ORAL18MGYesYes

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

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
N218764-001JASCAYDNERANDOMILAST9MGTABLET / ORALRLD2025-10-07
N218764-002JASCAYDNERANDOMILAST18MGTABLET / ORALRLD, RS2025-10-07

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218764-00187540732029-11-26U-4298Drug substance, Drug product2025-10-29
N218764-00186096702032-08-23Drug substance2025-10-29
N218764-00198029542034-02-19U-42982025-10-29
N218764-001114066382038-10-22U-42972025-10-29
N218764-001114066382038-10-22U-43732025-10-29
N218764-001118132662038-10-22U-42922025-10-29
N218764-001118132662038-10-22U-43722025-10-29
N218764-00287540732029-11-26U-4298Drug substance, Drug product2025-10-29
N218764-00286096702032-08-23Drug substance2025-10-29
N218764-00298029542034-02-19U-42982025-10-29
N218764-002114066382038-10-22U-42972025-10-29
N218764-002114066382038-10-22U-43732025-10-29
N218764-002118132662038-10-22U-42922025-10-29
N218764-002118132662038-10-22U-43722025-10-29

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218764-001I-9792028-12-19
N218764-001NCE2030-10-07
N218764-001ODE-5462032-10-07
N218764-002I-9792028-12-19
N218764-002NCE2030-10-07
N218764-002ODE-5462032-10-07

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 UTC2026-02N218764-001JASCAYD9MGTABLET / ORALRLD2025-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-002JASCAYD18MGTABLET / ORALRLD, RS2025-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-001JASCAYD9MGTABLET / ORALRLD2025-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-002JASCAYD18MGTABLET / ORALRLD, RS2025-10-0731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-001JASCAYD9MGTABLET / ORALRLD2025-10-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-002JASCAYD18MGTABLET / ORALRLD, RS2025-10-07a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N218764-00187540732029-11-26U-4298Drug substance, Drug product2025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-00186096702032-08-23Drug substance2025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-00198029542034-02-19U-42982025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-001114066382038-10-22U-43732025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-001114066382038-10-22U-42972025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-001118132662038-10-22U-43722025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-001118132662038-10-22U-42922025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-00287540732029-11-26U-4298Drug substance, Drug product2025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-00286096702032-08-23Drug substance2025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-00298029542034-02-19U-42982025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-002114066382038-10-22U-43732025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-002114066382038-10-22U-42972025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-002118132662038-10-22U-43722025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-002118132662038-10-22U-42922025-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-00187540732029-11-26U-4298Drug substance, Drug product2025-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-00186096702032-08-23Drug substance2025-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-00198029542034-02-19U-42982025-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-001114066382038-10-22U-42972025-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-001118132662038-10-22U-42922025-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-00287540732029-11-26U-4298Drug substance, Drug product2025-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-00286096702032-08-23Drug substance2025-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-00298029542034-02-19U-42982025-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-002114066382038-10-22U-42972025-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-002118132662038-10-22U-42922025-10-2931067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-00187540732029-11-26U-4298Drug substance, Drug product2025-10-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-00186096702032-08-23Drug substance2025-10-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-00198029542034-02-19U-42982025-10-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-001114066382038-10-22U-43732025-10-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-001114066382038-10-22U-42972025-10-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-001118132662038-10-22U-43722025-10-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-001118132662038-10-22U-42922025-10-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-00287540732029-11-26U-4298Drug substance, Drug product2025-10-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-00286096702032-08-23Drug substance2025-10-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-00298029542034-02-19U-42982025-10-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-002114066382038-10-22U-43732025-10-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-002114066382038-10-22U-42972025-10-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-002118132662038-10-22U-43722025-10-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-002118132662038-10-22U-42922025-10-29a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N218764-001I-9792028-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-001NCE2030-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-002I-9792028-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-002NCE2030-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-001NCE2030-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-002NCE2030-10-0731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-001I-9792028-12-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-001NCE2030-10-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-001ODE-5462032-10-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-002I-9792028-12-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-002NCE2030-10-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-002ODE-5462032-10-07a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JASCAYDNERANDOMILASTBoehringer Ingelheim Pharmaceuticals, Inc.fa1b14c6-957f-d326-5099-911bfe33e3912026-02-02Adverse reactionsExact identifier
application applno (NDA): 218764
application number: NDA218764

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85196SUPPL 2026-03-02
85195SUPPL 2026-03-02
84099ORIG 2025-11-06
83717ORIG 2025-10-10
83688ORIG 2025-10-07