FDA.reportPublic FDA data

Application 219407

Type
NDA
Sponsor
IONIS PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAWNZERA (AUTOINJECTOR)DONIDALORSEN SODIUMSOLUTION;SUBCUTANEOUSEQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)YesYes

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

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
N219407-001DAWNZERA (AUTOINJECTOR)DONIDALORSEN SODIUMEQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-08-21

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219407-00193158112032-10-21U-30102025-09-16
N219407-00191272762034-05-01Drug substance2025-09-16
N219407-00191815492034-05-01Drug substance2025-09-16
N219407-00196704922034-08-28Drug substance2025-09-16
N219407-001102944772035-05-01U-3010Drug substance, Drug product2025-09-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219407-001ODE-5502032-08-21

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 22:38:342026-08N219407-001DAWNZERA (AUTOINJECTOR)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-08-2184e616aacf4f…
2026-08-18 06:07:402026-07N219407-001DAWNZERA (AUTOINJECTOR)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-08-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219407-001DAWNZERA (AUTOINJECTOR)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219407-001DAWNZERA (AUTOINJECTOR)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-08-2131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219407-001DAWNZERA (AUTOINJECTOR)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-08-21a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N219407-00193158112032-10-21U-30102025-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N219407-00191272762034-05-01Drug substance2025-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N219407-00191815492034-05-01Drug substance2025-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N219407-00196704922034-08-28Drug substance2025-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N219407-001102944772035-05-01U-3010Drug substance, Drug product2025-09-1684e616aacf4f…
2026-08-18 06:07:402026-07N219407-00193158112032-10-21U-30102025-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219407-00191272762034-05-01Drug substance2025-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219407-00191815492034-05-01Drug substance2025-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219407-00196704922034-08-28Drug substance2025-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219407-001102944772035-05-01U-3010Drug substance, Drug product2025-09-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219407-00193158112032-10-21U-30102025-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219407-00191272762034-05-01Drug substance2025-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219407-00191815492034-05-01Drug substance2025-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219407-00196704922034-08-28Drug substance2025-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219407-001102944772035-05-01U-3010Drug substance, Drug product2025-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219407-00193158112032-10-21U-30102025-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219407-00191272762034-05-01Drug substance2025-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219407-00191815492034-05-01Drug substance2025-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219407-00196704922034-08-28Drug substance2025-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219407-001102944772035-05-01U-3010Drug substance, Drug product2025-09-1631067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219407-00193158112032-10-21U-30102025-09-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219407-00191272762034-05-01Drug substance2025-09-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219407-00191815492034-05-01Drug substance2025-09-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219407-00196704922034-08-28Drug substance2025-09-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219407-001102944772035-05-01U-3010Drug substance, Drug product2025-09-16a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N219407-001ODE-5502032-08-2184e616aacf4f…
2026-08-18 06:07:402026-07N219407-001ODE-5502032-08-21caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219407-001ODE-5502032-08-21a50c72e98297…

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
DAWNZERADONIDALORSENIonis Pharmaceuticals Inc.3ff501e0-f75f-07da-e063-6294a90a0cb72025-09-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 219407
application number: NDA219407

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83629ORIG 2025-10-02
83207ORIG 2025-08-27
83170ORIG 2025-08-22