Application 217779

Type: NDA
Sponsor: GERON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RYTELO	IMETELSTAT SODIUM	POWDER;INTRAVENOUS	EQ 47MG BASE/VIAL	Yes	Yes
002	RYTELO	IMETELSTAT SODIUM	POWDER;INTRAVENOUS	EQ 188MG BASE/VIAL	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217779-001	RYTELO	IMETELSTAT SODIUM	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-06
N217779-002	RYTELO	IMETELSTAT SODIUM	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-06

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217779-001	9388415	2026-09-09	U-3956		2024-07-03
N217779-001	9388416	2026-09-09	U-3956		2024-07-03
N217779-001	7494982	2026-12-27		Drug substance, Drug product	2024-07-03
N217779-001	12442000	2033-03-15	U-3956		2025-11-03
N217779-001	9375485	2033-03-15	U-3956		2024-07-03
N217779-001	12171778	2039-06-16	U-3956		2025-01-15
N217779-002	9388415	2026-09-09	U-3956		2024-07-03
N217779-002	9388416	2026-09-09	U-3956		2024-07-03
N217779-002	7494982	2026-12-27		Drug substance, Drug product	2024-07-03
N217779-002	12442000	2033-03-15	U-3956		2025-11-03
N217779-002	9375485	2033-03-15	U-3956		2024-07-03
N217779-002	12171778	2039-06-16	U-3956		2025-01-15

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217779-001	ODE-482	2031-06-06
N217779-002	ODE-482	2031-06-06

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217779-001	RYTELO	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217779-002	RYTELO	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217779-001	RYTELO	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217779-002	RYTELO	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217779-001	RYTELO	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217779-002	RYTELO	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217779-001	RYTELO	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217779-002	RYTELO	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217779-001	RYTELO	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217779-002	RYTELO	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217779-001	RYTELO	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217779-002	RYTELO	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217779-001	RYTELO	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217779-002	RYTELO	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217779-001	RYTELO	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217779-002	RYTELO	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217779-001	RYTELO	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217779-002	RYTELO	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217779-001	RYTELO	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217779-002	RYTELO	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217779-001	RYTELO	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217779-002	RYTELO	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217779-001	RYTELO	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217779-002	RYTELO	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217779-001	RYTELO	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217779-002	RYTELO	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217779-001	RYTELO	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217779-002	RYTELO	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217779-001	RYTELO	EQ 47MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217779-002	RYTELO	EQ 188MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-06	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 142 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217779-001	9388415	2026-09-09	U-3956		2024-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217779-001	9388416	2026-09-09	U-3956		2024-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217779-001	7494982	2026-12-27		Drug substance, Drug product	2024-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217779-001	12442000	2033-03-15	U-3956		2025-11-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217779-001	9375485	2033-03-15	U-3956		2024-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217779-001	12171778	2039-06-16	U-3956		2025-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217779-002	9388415	2026-09-09	U-3956		2024-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217779-002	9388416	2026-09-09	U-3956		2024-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217779-002	7494982	2026-12-27		Drug substance, Drug product	2024-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217779-002	12442000	2033-03-15	U-3956		2025-11-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217779-002	9375485	2033-03-15	U-3956		2024-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217779-002	12171778	2039-06-16	U-3956		2025-01-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217779-001	9388415	2026-09-09	U-3956		2024-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217779-001	9388416	2026-09-09	U-3956		2024-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217779-001	7494982	2026-12-27		Drug substance, Drug product	2024-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217779-001	12442000	2033-03-15	U-3956		2025-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217779-001	9375485	2033-03-15	U-3956		2024-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217779-001	12171778	2039-06-16	U-3956		2025-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217779-002	9388415	2026-09-09	U-3956		2024-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217779-002	9388416	2026-09-09	U-3956		2024-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217779-002	7494982	2026-12-27		Drug substance, Drug product	2024-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217779-002	12442000	2033-03-15	U-3956		2025-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217779-002	9375485	2033-03-15	U-3956		2024-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217779-002	12171778	2039-06-16	U-3956		2025-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217779-001	9388415	2026-09-09	U-3956		2024-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217779-001	9388416	2026-09-09	U-3956		2024-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217779-001	7494982	2026-12-27		Drug substance, Drug product	2024-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217779-001	12442000	2033-03-15	U-3956		2025-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217779-001	9375485	2033-03-15	U-3956		2024-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217779-001	12171778	2039-06-16	U-3956		2025-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217779-002	9388415	2026-09-09	U-3956		2024-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217779-002	9388416	2026-09-09	U-3956		2024-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217779-002	7494982	2026-12-27		Drug substance, Drug product	2024-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217779-002	12442000	2033-03-15	U-3956		2025-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217779-002	9375485	2033-03-15	U-3956		2024-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217779-002	12171778	2039-06-16	U-3956		2025-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217779-001	7494982	2025-12-27		Drug substance, Drug product	2024-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217779-001	9388415	2026-09-09	U-3956		2024-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217779-001	9388416	2026-09-09	U-3956		2024-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217779-001	12442000	2033-03-15	U-3956		2025-11-03	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N217779-001	ODE-482	2031-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217779-002	ODE-482	2031-06-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217779-001	ODE-482	2031-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217779-002	ODE-482	2031-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217779-001	ODE-482	2031-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217779-002	ODE-482	2031-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217779-001	ODE-482	2031-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217779-002	ODE-482	2031-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217779-001	ODE-482	2031-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217779-002	ODE-482	2031-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217779-001	ODE-482	2031-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217779-002	ODE-482	2031-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217779-001	ODE-482	2031-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217779-002	ODE-482	2031-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217779-001	ODE-482	2031-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217779-002	ODE-482	2031-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217779-001	ODE-482	2031-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217779-002	ODE-482	2031-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217779-001	ODE-482	2031-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217779-002	ODE-482	2031-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217779-001	ODE-482	2031-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217779-002	ODE-482	2031-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217779-001	ODE-482	2031-06-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217779-002	ODE-482	2031-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217779-001	ODE-482	2031-06-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217779-002	ODE-482	2031-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217779-001	ODE-482	2031-06-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217779-002	ODE-482	2031-06-06	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217779-001	ODE-482	2031-06-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217779-002	ODE-482	2031-06-06	`a50c72e98297…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RYTELO	IMETELSTAT SODIUM	Geron Corporation	b0fab7ca-e578-43c5-9df6-bdaff4182257	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217779 application number: NDA217779

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85693	SUPPL	2026-04-15
78983	ORIG	2024-07-08
78743	ORIG	2024-06-07
78742	ORIG	2024-06-07
78741	ORIG	2024-06-07