Application 210884

Type: NDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOSYMRA	SUMATRIPTAN	SPRAY;NASAL	10MG/SPRAY	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N210884-001	TOSYMRA	SUMATRIPTAN	10MG/SPRAY	SPRAY / NASAL		RLD, RS	2019-01-25

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210884-001	8268791	2026-05-09		Drug product	2019-02-21
N210884-001	8440631	2026-05-09	U-1719	Drug product	2019-02-21
N210884-001	9283280	2026-05-09		Drug product	2019-02-21
N210884-001	10603305	2030-06-16	U-1719	Drug product	2020-03-31
N210884-001	11337962	2030-06-16	U-1719	Drug product	2022-05-25
N210884-001	12090139	2030-06-16		Drug product	2024-10-17
N210884-001	9610280	2030-06-16	U-1719	Drug product	2019-02-21
N210884-001	9974770	2030-06-16	U-1719	Drug product	2019-02-21
N210884-001	9211282	2031-07-19	U-1719	Drug product	2019-02-21

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N210884-001	TOSYMRA	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2019-01-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210884-001	TOSYMRA	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2019-01-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210884-001	TOSYMRA	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2019-01-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210884-001	TOSYMRA	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2019-01-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 348 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N210884-001	8268791	2026-05-09		Drug product	2019-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210884-001	8440631	2026-05-09	U-1719	Drug product	2019-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210884-001	9283280	2026-05-09		Drug product	2019-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210884-001	10603305	2030-06-16	U-1719	Drug product	2020-03-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210884-001	11337962	2030-06-16	U-1719	Drug product	2022-05-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210884-001	12090139	2030-06-16		Drug product	2024-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210884-001	9610280	2030-06-16	U-1719	Drug product	2019-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210884-001	9974770	2030-06-16	U-1719	Drug product	2019-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210884-001	9211282	2031-07-19	U-1719	Drug product	2019-02-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210884-001	8268791	2026-05-09		Drug product	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210884-001	8440631	2026-05-09	U-1719	Drug product	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210884-001	9283280	2026-05-09		Drug product	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210884-001	10603305	2030-06-16	U-1719	Drug product	2020-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210884-001	11337962	2030-06-16	U-1719	Drug product	2022-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210884-001	12090139	2030-06-16		Drug product	2024-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210884-001	9610280	2030-06-16	U-1719	Drug product	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210884-001	9974770	2030-06-16	U-1719	Drug product	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210884-001	9211282	2031-07-19	U-1719	Drug product	2019-02-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210884-001	8268791	2026-05-09		Drug product	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210884-001	8440631	2026-05-09	U-1719	Drug product	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210884-001	9283280	2026-05-09		Drug product	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210884-001	10603305	2030-06-16	U-1719	Drug product	2020-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210884-001	11337962	2030-06-16	U-1719	Drug product	2022-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210884-001	12090139	2030-06-16		Drug product	2024-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210884-001	9610280	2030-06-16	U-1719	Drug product	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210884-001	9974770	2030-06-16	U-1719	Drug product	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210884-001	9211282	2031-07-19	U-1719	Drug product	2019-02-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210884-001	8268791	2026-05-09		Drug product	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210884-001	8440631	2026-05-09	U-1719	Drug product	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210884-001	9283280	2026-05-09		Drug product	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210884-001	10603305	2030-06-16	U-1719	Drug product	2020-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210884-001	11337962	2030-06-16	U-1719	Drug product	2022-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210884-001	12090139	2030-06-16		Drug product	2024-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210884-001	9610280	2030-06-16	U-1719	Drug product	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210884-001	9974770	2030-06-16	U-1719	Drug product	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210884-001	9211282	2031-07-19	U-1719	Drug product	2019-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210884-001	8268791	2026-05-09		Drug product	2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210884-001	8440631	2026-05-09	U-1719	Drug product	2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210884-001	9283280	2026-05-09		Drug product	2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210884-001	10603305	2030-06-16	U-1719	Drug product	2020-03-31	`31067a03dcf5…`

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
Tosymra	SUMATRIPTAN	Tonix Medicines, Inc.	d9f682f0-d50a-4fe6-ab1b-e5a7ec27b3a5	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210884 application number: NDA210884
TOSYMRA	SUMATRIPTAN	Upsher-Smith Laboratories, LLC	015a5cf9-f246-48bc-b91e-cd730a53d8aa	2024-11-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210884 application number: NDA210884 ndc (product): 0245-0812

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0245-0812	TOSYMRA	sumatriptan	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0812	TOSYMRA	sumatriptan	Upsher-Smith Laboratories, LLC	NDA	Current
67857-812	TOSYMRA	sumatriptan	Promius Pharma, LLC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59999	ORIG	2019-09-13
57549	ORIG	2019-02-13
57387	ORIG	2019-01-30