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 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
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
2026-09-14 22:38:342026-08N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-0484e616aacf4f…
2026-08-18 06:07:402026-07N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04caaa826d4ba7…
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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N217225-00182367732026-11-11U-36732023-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N217225-00175794562027-02-14Drug substance2023-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N217225-00196175462027-02-14U-3673Drug substance2023-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N217225-001112731712034-07-11U-36732023-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N217225-001114911762034-07-11U-36732023-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N217225-001120168752034-07-11U-36732024-10-0184e616aacf4f…
2026-08-18 06:07:402026-07N217225-00182367732026-11-11U-36732023-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N217225-00175794562027-02-14Drug substance2023-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N217225-00196175462027-02-14U-3673Drug substance2023-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N217225-001112731712034-07-11U-36732023-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N217225-001114911762034-07-11U-36732023-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N217225-001120168752034-07-11U-36732024-10-01caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

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

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