Application 208223

Type: NDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZEMBRACE SYMTOUCH	SUMATRIPTAN SUCCINATE	SOLUTION;SUBCUTANEOUS	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	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
N208223-001	ZEMBRACE SYMTOUCH	SUMATRIPTAN SUCCINATE	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS		RLD	2016-01-28

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208223-001	10537554	2036-01-29	U-72		2020-01-21
N208223-001	11364224	2036-01-29	U-72		2022-06-21
N208223-001	12097183	2036-01-29		Drug product	2024-10-24

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.

Product history page 1 of 2 · 42 observed 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	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 77 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	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`5c6f7cd8ea54…`

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
ZEMBRACE SYMTOUCH	SUMATRIPTAN SUCCINATE	Upsher-Smith laboratories, LLC	6e5b104f-2b9e-416e-92fb-ef1bdaea867d	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208223 application number: NDA208223 ndc (product): 0245-0809
Zembrace SymTouch	SUMATRIPTAN SUCCINATE	Tonix Medicines, Inc.	3eb49807-fa9d-4a0d-9a3c-76de5b23b01b	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208223 application number: NDA208223

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0245-0809	ZEMBRACE SYMTOUCH	Sumatriptan Succinate	Upsher-Smith laboratories, LLC	NDA	Current
0245-0809	ZEMBRACE SYMTOUCH	Sumatriptan Succinate	Upsher-Smith laboratories, LLC	NDA	Current
0245-0809	ZEMBRACE SYMTOUCH	Sumatriptan Succinate	Upsher-Smith laboratories, LLC	NDA	Current
67857-809	ZEMBRACE SymTouch	sumatriptan	Promius Pharma, LLC	NDA	Current
67857-809	ZEMBRACE SymTouch	sumatriptan	Promius Pharma, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59014	SUPPL	2019-06-12
59011	SUPPL	2019-06-11
50197	ORIG	2017-10-26
47692	SUPPL	2017-03-28
47626	SUPPL	2017-03-28
40627	ORIG	2016-02-11
32899	ORIG	2016-02-01