Application 022239

Type: NDA
Sponsor: ENDO VENTURES LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUMAVEL DOSEPRO	SUMATRIPTAN SUCCINATE	INJECTABLE;SUBCUTANEOUS	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	Yes	No
002	SUMAVEL DOSEPRO	SUMATRIPTAN SUCCINATE	INJECTABLE;SUBCUTANEOUS	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022239-001	SUMAVEL DOSEPRO	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD	2009-07-15
N022239-002	SUMAVEL DOSEPRO	SUMATRIPTAN SUCCINATE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD	2013-11-26

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022239-001	7901385	2026-07-31		Drug product	2011-03-23
N022239-001	7776007	2026-11-22		Drug product	2011-03-04

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 247 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`8072bd15b7f6…`

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 3 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Asclemed USA, Inc.	b16886d0-224b-4d83-85c4-bc3eb3606c17	2020-10-24	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
sumatriptan succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	d556563f-ad71-45c1-829a-cc11983bce0c	2020-03-01	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	68daf82a-334e-43ca-b4bb-5c66a82f52c8	2020-02-01	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	77a41cca-02d2-4b84-975e-d1925f0fca80	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	d9c78ac5-7328-4204-8f66-96606d7db5c3	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	44d6d757-489c-4262-a518-af8c470734d6	2019-10-01	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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43376-104	Sumavel DosePro	sumatriptan	Zogenix, Inc.	NDA	Current
43376-106	Sumavel DosePro	sumatriptan	Zogenix, Inc.	NDA	Current
63481-367	Sumavel DosePro	sumatriptan	Endo Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63807	SUPPL	2020-07-06
63798	SUPPL	2020-07-06
61500	SUPPL	2020-01-02
61461	SUPPL	2019-12-27
17111	SUPPL	2016-06-06
38412	SUPPL	2013-12-12
7078	SUPPL	2013-11-27
29433	SUPPL	2011-07-05
38411	SUPPL	2011-06-27
44711	ORIG	2010-06-22
21966	ORIG	2010-06-22
17110	ORIG	2009-07-23
7077	ORIG	2009-07-20