Application 214096

Type: NDA
Sponsor: EMD SERONO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEPMETKO	TEPOTINIB HYDROCHLORIDE	TABLET;ORAL	225MG	Yes	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214096-001	TEPMETKO	TEPOTINIB HYDROCHLORIDE	EQ 225MG BASE	TABLET / ORAL		RLD, RS	2021-02-03

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214096-001	9284300	2028-04-29		Drug product	2021-03-03
N214096-001	8921357	2028-05-30		Drug substance, Drug product	2021-03-03
N214096-001	8658643	2028-07-04	U-3077		2021-03-03
N214096-001	9062029	2028-07-04		Drug product	2021-03-03
N214096-001	9403799	2028-07-04	U-3077		2021-03-03
N214096-001	8927540	2028-07-21	U-3078		2021-03-03
N214096-001	8329692	2029-10-30		Drug substance, Drug product	2021-03-03
N214096-001	8580781	2030-03-19		Drug substance, Drug product	2021-03-03

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214096-001	NCE	2026-02-03
N214096-001	ODE-325	2028-02-03

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
2026-02-19 14:30 UTC	2026-02	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 272 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214096-001	9284300	2028-04-29		Drug product	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	8921357	2028-05-30		Drug substance, Drug product	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	8658643	2028-07-04	U-3077		2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	9062029	2028-07-04		Drug product	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	9403799	2028-07-04	U-3077		2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	8927540	2028-07-21	U-3078		2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	8329692	2029-10-30		Drug substance, Drug product	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	8580781	2030-03-19		Drug substance, Drug product	2021-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	9284300	2028-04-29		Drug product	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	8921357	2028-05-30		Drug substance, Drug product	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	8658643	2028-07-04	U-3077		2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	9062029	2028-07-04		Drug product	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	9403799	2028-07-04	U-3077		2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	8927540	2028-07-21	U-3078		2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	8329692	2029-10-30		Drug substance, Drug product	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	8580781	2030-03-19		Drug substance, Drug product	2021-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214096-001	9284300	2028-04-29		Drug product	2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	8921357	2028-05-30		Drug substance, Drug product	2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	8658643	2028-07-04	U-3077		2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	9062029	2028-07-04		Drug product	2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	9403799	2028-07-04	U-3077		2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	8927540	2028-07-21	U-3078		2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	8329692	2029-10-30		Drug substance, Drug product	2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	8580781	2030-03-19		Drug substance, Drug product	2021-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	9284300	2028-04-29		Drug product	2021-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	8921357	2028-05-30		Drug substance, Drug product	2021-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	8658643	2028-07-04	U-3077		2021-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	9062029	2028-07-04		Drug product	2021-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	9403799	2028-07-04	U-3077		2021-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	8927540	2028-07-21	U-3078		2021-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	8329692	2029-10-30		Drug substance, Drug product	2021-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	8580781	2030-03-19		Drug substance, Drug product	2021-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	9284300	2028-04-29		Drug product	2021-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	8921357	2028-05-30		Drug substance, Drug product	2021-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	8658643	2028-07-04	U-3077		2021-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	9062029	2028-07-04		Drug product	2021-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	9403799	2028-07-04	U-3077		2021-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	8927540	2028-07-21	U-3078		2021-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	8329692	2029-10-30		Drug substance, Drug product	2021-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	8580781	2030-03-19		Drug substance, Drug product	2021-03-03	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214096-001	NCE	2026-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	ODE-325	2028-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	NCE	2026-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	ODE-325	2028-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214096-001	NCE	2026-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	ODE-325	2028-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	NCE	2026-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	ODE-325	2028-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	NCE	2026-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	ODE-325	2028-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214096-001	NCE	2026-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214096-001	ODE-325	2028-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214096-001	NCE	2026-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214096-001	ODE-325	2028-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214096-001	NCE	2026-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214096-001	ODE-325	2028-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214096-001	NCE	2026-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214096-001	ODE-325	2028-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214096-001	NCE	2026-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214096-001	ODE-325	2028-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214096-001	NCE	2026-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214096-001	ODE-325	2028-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214096-001	NCE	2026-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214096-001	ODE-325	2028-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214096-001	NCE	2026-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214096-001	ODE-325	2028-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214096-001	NCE	2026-02-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214096-001	ODE-325	2028-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214096-001	NCE	2026-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214096-001	ODE-325	2028-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214096-001	NCE	2026-02-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214096-001	ODE-325	2028-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214096-001	NCE	2026-02-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214096-001	ODE-325	2028-02-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214096-001	NCE	2026-02-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214096-001	ODE-325	2028-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214096-001	NCE	2026-02-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N214096-001	ODE-325	2028-02-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214096-001	NCE	2026-02-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214096-001	ODE-325	2028-02-03	`87673890dc5c…`

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
TEPMETKO	TEPOTINIB HYDROCHLORIDE	EMD Serono, Inc.	80a0f1b9-071a-47f5-9e67-32d638a669dc	2025-04-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214096 application number: NDA214096 ndc (product): 44087-5000

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44087-5000	TEPMETKO	Tepotinib Hydrochloride	EMD Serono, Inc.	NDA	Current
44087-5000	TEPMETKO	Tepotinib Hydrochloride	EMD Serono, Inc.	NDA	Current
44087-5000	TEPMETKO	Tepotinib Hydrochloride	EMD Serono, Inc.	NDA	Current
44087-5000	TEPMETKO	Tepotinib Hydrochloride	EMD Serono, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84055	SUPPL	2025-11-19
77525	SUPPL	2024-02-16
77508	SUPPL	2024-02-16
73862	SUPPL	2023-03-24
73861	SUPPL	2023-03-24
73859	SUPPL	2023-03-24
73858	SUPPL	2023-03-24
66311	ORIG	2021-02-22
66095	ORIG	2021-02-05
66080	ORIG	2021-02-03