FDA.reportPublic FDA data

Application 219876

Type
NDA
Sponsor
CHIMERIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MODEYSODORDAVIPRONE HYDROCHLORIDECAPSULE;ORALEQ 125MG BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N219876-001MODEYSODORDAVIPRONE HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALRLD, RS2025-08-06

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219876-00196298422032-04-30U-42542025-09-03
N219876-001RE462902032-04-30U-42542025-09-03
N219876-00192657652034-07-26Drug product2025-09-03
N219876-001119760682036-03-01Drug product2025-09-03
N219876-001101728622037-01-30U-42542025-09-03
N219876-001103691542037-01-30U-42542025-09-03
N219876-001121026392037-01-30U-42542025-09-03

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219876-001NCE2030-08-06
N219876-001ODE-5472032-08-06

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
2026-08-18 06:07:402026-07N219876-001MODEYSOEQ 125MG BASECAPSULE / ORALRLD, RS2025-08-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219876-001MODEYSOEQ 125MG BASECAPSULE / ORALRLD, RS2025-08-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219876-001MODEYSOEQ 125MG BASECAPSULE / ORALRLD, RS2025-08-0631067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219876-001MODEYSOEQ 125MG BASECAPSULE / ORALRLD, RS2025-08-06a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N219876-00196298422032-04-30U-42542025-09-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219876-001RE462902032-04-30U-42542025-09-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219876-00192657652034-07-26Drug product2025-09-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219876-001119760682036-03-01Drug product2025-09-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219876-001101728622037-01-30U-42542025-09-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219876-001103691542037-01-30U-42542025-09-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219876-001121026392037-01-30U-42542025-09-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219876-00196298422032-04-30U-42542025-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219876-001RE462902032-04-30U-42542025-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219876-00192657652034-07-26Drug product2025-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219876-001119760682036-03-01Drug product2025-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219876-001101728622037-01-30U-42542025-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219876-001103691542037-01-30U-42542025-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219876-001121026392037-01-30U-42542025-09-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219876-00196298422032-04-30U-42542025-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219876-001RE462902032-04-30U-42542025-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219876-00192657652034-07-26Drug product2025-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219876-001119760682036-03-01Drug product2025-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219876-001101728622037-01-30U-42542025-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219876-001103691542037-01-30U-42542025-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219876-001121026392037-01-30U-42542025-09-0331067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219876-00196298422032-04-30U-42542025-09-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219876-001RE462902032-04-30U-42542025-09-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219876-00192657652034-07-26Drug product2025-09-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219876-001119760682036-03-01Drug product2025-09-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219876-001101728622037-01-30U-42542025-09-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219876-001103691542037-01-30U-42542025-09-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219876-001121026392037-01-30U-42542025-09-03a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N219876-001NCE2030-08-06caaa826d4ba7…
2026-08-18 06:07:402026-07N219876-001ODE-5472032-08-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219876-001NCE2030-08-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219876-001NCE2030-08-0631067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219876-001NCE2030-08-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219876-001ODE-5472032-08-06a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MODEYSODORDAVIPRONEJazz Pharmaceuticals, Inc.ad45b43e-fdef-47ad-9c34-055b41bdc5762026-01-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 219876
application number: NDA219876

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83246ORIG 2025-09-02
83061ORIG 2025-08-07
83057ORIG 2025-08-06