Application 206099

Type: NDA
Sponsor: CURRAX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONZETRA XSAIL	SUMATRIPTAN SUCCINATE	POWDER;NASAL	EQ 11MG BASE	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
N206099-001	ONZETRA XSAIL	SUMATRIPTAN SUCCINATE	EQ 11MG BASE	POWDER / NASAL		RLD	2016-01-27

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206099-001	11571531	2026-02-23	U-1809		2023-05-19
N206099-001	10124132	2027-03-06	U-1719	Drug product	2018-12-10
N206099-001	10124132	2027-03-06	U-2010	Drug product	2018-12-10
N206099-001	10124132	2027-03-06	U-2011	Drug product	2018-12-10
N206099-001	10398859	2027-12-19		Drug product	2019-09-30
N206099-001	8875704	2028-04-07	U-1809	Drug product	2016-02-23
N206099-001	10722667	2028-12-30		Drug product	2020-08-25
N206099-001	10076615	2029-07-30	U-2010		2018-10-12
N206099-001	10076615	2029-07-30	U-2011		2018-10-12
N206099-001	10076615	2029-07-30	U-2404		2018-10-12
N206099-001	8550073	2029-10-22		Drug product	2016-02-23
N206099-001	8899229	2030-08-18		Drug product	2016-02-23
N206099-001	9649456	2030-10-21	U-1719	Drug product	2017-05-26
N206099-001	9649456	2030-10-21	U-2010	Drug product	2017-05-26
N206099-001	9649456	2030-10-21	U-2011	Drug product	2017-05-26
N206099-001	8978647	2030-12-06		Drug product	2016-02-23
N206099-001	10478574	2033-11-04	U-2404		2019-12-09
N206099-001	10076614	2034-10-20		Drug product	2018-10-12

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.

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	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 25 · 976 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	N206099-001	11571531	2026-02-23	U-1809		2023-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	10124132	2027-03-06	U-2010	Drug product	2018-12-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	10124132	2027-03-06	U-1719	Drug product	2018-12-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	10124132	2027-03-06	U-2011	Drug product	2018-12-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	10398859	2027-12-19		Drug product	2019-09-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	8875704	2028-04-07	U-1809	Drug product	2016-02-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	10722667	2028-12-30		Drug product	2020-08-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	10076615	2029-07-30	U-2011		2018-10-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	10076615	2029-07-30	U-2010		2018-10-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	10076615	2029-07-30	U-2404		2018-10-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	8550073	2029-10-22		Drug product	2016-02-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	8899229	2030-08-18		Drug product	2016-02-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	9649456	2030-10-21	U-1719	Drug product	2017-05-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	9649456	2030-10-21	U-2011	Drug product	2017-05-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	9649456	2030-10-21	U-2010	Drug product	2017-05-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	8978647	2030-12-06		Drug product	2016-02-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	10478574	2033-11-04	U-2404		2019-12-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206099-001	10076614	2034-10-20		Drug product	2018-10-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N206099-001	11571531	2026-02-23	U-1809		2023-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	10124132	2027-03-06	U-2010	Drug product	2018-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	10124132	2027-03-06	U-1719	Drug product	2018-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	10124132	2027-03-06	U-2011	Drug product	2018-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	10398859	2027-12-19		Drug product	2019-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	8875704	2028-04-07	U-1809	Drug product	2016-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	10722667	2028-12-30		Drug product	2020-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	10076615	2029-07-30	U-2011		2018-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	10076615	2029-07-30	U-2010		2018-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	10076615	2029-07-30	U-2404		2018-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	8550073	2029-10-22		Drug product	2016-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	8899229	2030-08-18		Drug product	2016-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	9649456	2030-10-21	U-1719	Drug product	2017-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	9649456	2030-10-21	U-2011	Drug product	2017-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	9649456	2030-10-21	U-2010	Drug product	2017-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	8978647	2030-12-06		Drug product	2016-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	10478574	2033-11-04	U-2404		2019-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206099-001	10076614	2034-10-20		Drug product	2018-10-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206099-001	11571531	2026-02-23	U-1809		2023-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	10124132	2027-03-06	U-2010	Drug product	2018-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	10124132	2027-03-06	U-1719	Drug product	2018-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	10124132	2027-03-06	U-2011	Drug product	2018-12-10	`caaa826d4ba7…`

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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sumatriptan	SUMATRIPTAN SUCCINATE	Preferred Pharmaceuticals, Inc.	bf9fd9fe-095b-4478-bd2e-a5534af07761	2026-09-03	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	Preferred Pharmaceuticals Inc.	baf37e8c-d414-4ca7-a366-97dc202372ff	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Mylan Pharmaceuticals Inc.	1d2cd01c-05e7-44cf-a71d-0f474e826b7e	2026-08-26	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Sportpharm LLC	7d3602a1-1cd5-41c2-a0a3-3d20e90a92fa	2026-07-09	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
sumatriptan succinate	SUMATRIPTAN SUCCINATE	Sun Pharmaceutical Industries, Inc.	9485cc30-15e8-4b53-876d-db317145474b	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	REMEDYREPACK INC.	73c9ac06-b55e-41e0-90ec-deb250f37eb5	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	Aurobindo Pharma Limited	b2503fff-c978-4efa-b1b4-d7740b6b26f2	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	Sportpharm LLC	d071aef6-a5bd-4f68-ba6d-03004466897c	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Golden State Medical Supply, Inc.	1bf70380-8272-4c0d-8841-d39ef2772351	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Dr. Reddy's Laboratories Limited	ac80d018-6abf-2e41-ddea-90b4ff9e9013	2026-03-21	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	A-S Medication Solutions	62ba6fef-467a-4500-993c-51907f12a67c	2026-02-14	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	NorthStar Rx LLC	84bfc4ba-4172-4adb-b963-4e0eb438c07a	2026-02-13	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	Alembic Pharmaceuticals Inc.	0e8b65f7-9d3b-42f2-8d7e-69b143365980	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Dr. Reddys Laboratories Inc.,	8fef1176-7a38-eca3-22ca-83efe5ca6620	2026-01-21	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Sun Pharmaceutical Industries, Inc.	f235152e-dd8d-4679-9d9f-404fe5ff4fba	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	Alembic Pharmaceuticals Limited	16b7e44d-afa0-4177-80ef-c3ae9a78a4e1	2025-11-17	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	Preferred Pharmaceuticals, Inc.	f2e7d756-1e12-462a-a43f-a9d860b11ee8	2025-09-25	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Zembrace SymTouch	SUMATRIPTAN SUCCINATE	Tonix Medicines, Inc.	3eb49807-fa9d-4a0d-9a3c-76de5b23b01b	2025-02-28	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	NuCare Pharmaceuticals, Inc.	2efd4269-5657-9669-e063-6394a90a583a	2025-02-25	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Direct_Rx	f6c95873-576d-a1c2-e053-6294a90a3ff9	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42847-311	Onzetra Xsail	sumatriptan succinate	Currax Pharmaceuticals LLC	NDA	Current
42847-311	Onzetra Xsail	sumatriptan succinate	Currax Pharmaceuticals LLC	NDA	Current
42847-311	Onzetra Xsail	sumatriptan succinate	Currax Pharmaceuticals LLC	NDA	Current
64597-311	ONZETRA	sumatriptan succinate	Avanir Pharmaceuticals, Inc.	NDA	Current
64597-311	ONZETRA	sumatriptan succinate	Avanir Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61445	SUPPL	2019-12-26
61394	SUPPL	2019-12-23
59132	SUPPL	2019-06-20
59121	SUPPL	2019-06-19
23012	ORIG	2016-07-19
19705	ORIG	2016-02-18
10545	ORIG	2016-01-29