FDA.reportPublic FDA data

Application 217225

Type
NDA
Sponsor
ASTELLAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IZERVAYAVACINCAPTAD PEGOL SODIUMSOLUTION;INTRAVITREALEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)YesYes

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
N217225-001IZERVAYAVACINCAPTAD PEGOL SODIUMEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217225-00182367732026-11-11U-36732023-08-31
N217225-00175794562027-02-14Drug substance2023-08-31
N217225-00196175462027-02-14U-3673Drug substance2023-08-31
N217225-001112731712034-07-11U-36732023-08-31
N217225-001114911762034-07-11U-36732023-08-31
N217225-001120168752034-07-11U-36732024-10-01

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 UTC2026-02N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-048072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-049b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N217225-00182367732026-11-11U-36732023-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217225-00175794562027-02-14Drug substance2023-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217225-00196175462027-02-14U-3673Drug substance2023-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217225-001112731712034-07-11U-36732023-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217225-001114911762034-07-11U-36732023-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217225-001120168752034-07-11U-36732024-10-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-001109475442025-02-14U-3673Drug substance2023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-00175382112025-02-14Drug substance2023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-00178039312025-02-14Drug substance2023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-00175794562026-02-14Drug substance2023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-00196175462026-02-14U-3673Drug substance2023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-00182367732026-11-11U-36732023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-001112731712034-07-11U-36732023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-001114911762034-07-11U-36732023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-001120168752034-07-11U-36732024-10-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N217225-001109475442025-02-14U-3673Drug substance2023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-00175382112025-02-14Drug substance2023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-00178039312025-02-14Drug substance2023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-00175794562026-02-14Drug substance2023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-00196175462026-02-14U-3673Drug substance2023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-00182367732026-11-11U-36732023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-001112731712034-07-11U-36732023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-001114911762034-07-11U-36732023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-001120168752034-07-11U-36732024-10-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-001109475442025-02-14U-3673Drug substance2023-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-00175382112025-02-14Drug substance2023-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-00178039312025-02-14Drug substance2023-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-00175794562026-02-14Drug substance2023-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-00196175462026-02-14U-3673Drug substance2023-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-00182367732026-11-11U-36732023-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-001112731712034-07-11U-36732023-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-001114911762034-07-11U-36732023-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-001120168752034-07-11U-36732024-10-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-001109475442025-02-14U-3673Drug substance2023-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-00175382112025-02-14Drug substance2023-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-00175794562025-02-14Drug substance2023-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-00178039312025-02-14Drug substance2023-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-00196175462025-02-14U-3673Drug substance2023-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-00182367732026-11-11U-36732023-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-001112731712034-07-11U-36732023-08-31b8a1b40f171c…

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
IZERVAYAVACINCAPTAD PEGOLAstellas Pharma US, Inc.1642fe6a-dc26-4d20-ae6e-654af744e3bd2026-02-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 217225
application number: NDA217225

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85278SUPPL 2026-03-06
85209SUPPL 2026-03-06
81250SUPPL 2025-02-14
81240SUPPL 2025-02-13
75344ORIG 2023-09-01
75019ORIG 2023-08-08
75011ORIG 2023-08-07