Application 214200

Type: NDA
Sponsor: G1 THERAPEUTICS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COSELA	TRILACICLIB	INJECTABLE;INJECTION	300MG	Yes	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214200-001	COSELA	TRILACICLIB DIHYDROCHLORIDE	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2021-02-12

Orange Book patents#

Current patent rows page 1 of 1 · 17 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214200-001	10189849	2031-10-25		Drug substance	2021-03-10
N214200-001	10189850	2031-10-25		Drug product	2021-03-10
N214200-001	10927120	2031-10-25		Drug product	2021-03-10
N214200-001	11040042	2031-10-25		Drug product	2021-07-21
N214200-001	8598197	2031-10-25		Drug substance, Drug product	2021-03-10
N214200-001	9957276	2031-10-25		Drug substance	2021-03-10
N214200-001	10085992	2034-03-14	U-3081		2021-03-10
N214200-001	10966984	2034-03-14	U-3079		2021-05-06
N214200-001	10966984	2034-03-14	U-3080		2021-05-06
N214200-001	11717523	2034-03-14	U-3678		2023-08-30
N214200-001	11717523	2034-03-14	U-3679		2023-08-30
N214200-001	9487530	2034-03-14	U-3079		2021-03-10
N214200-001	9487530	2034-03-14	U-3080		2021-03-10
N214200-001	8598186	2034-12-30		Drug substance, Drug product	2021-03-10
N214200-001	12527798	2037-12-05	U-3504		2026-01-21
N214200-001	11529352	2039-07-23	U-3504		2023-01-12
N214200-001	12168666	2040-11-13		Drug substance, Drug product	2025-01-13

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214200-001	NCE	2026-02-12

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
2026-08-18 06:07:40	2026-07	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214200-001	COSELA	EQ 300MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-02-12	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 493 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214200-001	10189849	2031-10-25		Drug substance	2021-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	10189850	2031-10-25		Drug product	2021-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	10927120	2031-10-25		Drug product	2021-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	11040042	2031-10-25		Drug product	2021-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	8598197	2031-10-25		Drug substance, Drug product	2021-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	9957276	2031-10-25		Drug substance	2021-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	10085992	2034-03-14	U-3081		2021-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	10966984	2034-03-14	U-3079		2021-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	10966984	2034-03-14	U-3080		2021-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	11717523	2034-03-14	U-3678		2023-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	11717523	2034-03-14	U-3679		2023-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	9487530	2034-03-14	U-3079		2021-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	9487530	2034-03-14	U-3080		2021-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	8598186	2034-12-30		Drug substance, Drug product	2021-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	12527798	2037-12-05	U-3504		2026-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	11529352	2039-07-23	U-3504		2023-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214200-001	12168666	2040-11-13		Drug substance, Drug product	2025-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214200-001	10189849	2031-10-25		Drug substance	2021-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	10189850	2031-10-25		Drug product	2021-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	10927120	2031-10-25		Drug product	2021-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	11040042	2031-10-25		Drug product	2021-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	8598197	2031-10-25		Drug substance, Drug product	2021-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	9957276	2031-10-25		Drug substance	2021-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	10085992	2034-03-14	U-3081		2021-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	10966984	2034-03-14	U-3079		2021-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	10966984	2034-03-14	U-3080		2021-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	11717523	2034-03-14	U-3678		2023-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	11717523	2034-03-14	U-3679		2023-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	9487530	2034-03-14	U-3079		2021-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	9487530	2034-03-14	U-3080		2021-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	8598186	2034-12-30		Drug substance, Drug product	2021-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	12527798	2037-12-05	U-3504		2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	11529352	2039-07-23	U-3504		2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214200-001	12168666	2040-11-13		Drug substance, Drug product	2025-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214200-001	10189849	2031-10-25		Drug substance	2021-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214200-001	10189850	2031-10-25		Drug product	2021-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214200-001	10927120	2031-10-25		Drug product	2021-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214200-001	11040042	2031-10-25		Drug product	2021-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214200-001	8598197	2031-10-25		Drug substance, Drug product	2021-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214200-001	9957276	2031-10-25		Drug substance	2021-03-10	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N214200-001	NCE	2026-02-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214200-001	NCE	2026-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214200-001	NCE	2026-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214200-001	NCE	2026-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214200-001	NCE	2026-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214200-001	NCE	2026-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214200-001	NCE	2026-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214200-001	NCE	2026-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214200-001	NCE	2026-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214200-001	NCE	2026-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214200-001	NCE	2026-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214200-001	NCE	2026-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214200-001	NCE	2026-02-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214200-001	NCE	2026-02-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214200-001	NCE	2026-02-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214200-001	NCE	2026-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214200-001	NCE	2026-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214200-001	NCE	2026-02-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214200-001	NCE	2026-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214200-001	NCE	2026-02-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214200-001	NCE	2026-02-12	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214200-001	NCE	2026-02-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214200-001	NCE	2026-02-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214200-001	NCE	2026-02-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214200-001	NCE	2026-02-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214200-001	NCE	2026-02-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214200-001	NCE	2026-02-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214200-001	NCE	2026-02-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214200-001	NCE	2026-02-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214200-001	NCE	2026-02-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214200-001	NCE	2026-02-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214200-001	NCE	2026-02-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214200-001	NCE	2026-02-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214200-001	NCE	2026-02-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214200-001	NCE	2026-02-12	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COSELA	TRILACICLIB	Pharmacosmos Therapeutics Inc.	b3179c19-78f3-4bf1-b73e-7f7638522ab1	2025-08-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214200 application number: NDA214200
COSELA	TRILACICLIB	G1 Therapeutics, Inc.	4b06922c-498d-4871-a037-84a44e6a6b6c	2024-02-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214200 application number: NDA214200 ndc (product): 73462-101

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
73462-101	Cosela	trilaciclib	G1 Therapeutics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83213	SUPPL	2025-08-27
83198	SUPPL	2025-08-26
74999	SUPPL	2023-08-04
74981	SUPPL	2023-08-04
73967	SUPPL	2023-04-10
73954	SUPPL	2023-04-06
66773	ORIG	2021-03-12
66579	ORIG	2021-03-08
66228	ORIG	2021-02-16