Application 202278

Type: NDA
Sponsor: TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZECUITY	SUMATRIPTAN SUCCINATE	SYSTEM;IONTOPHORESIS	EQ 6.5MG BASE/4HR	Yes	No

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

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
N202278-001	ZECUITY	SUMATRIPTAN SUCCINATE	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS		RLD	2013-01-17

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
N202278-001	7973058	2027-04-12	U-1328		2013-02-15
N202278-001	8155737	2027-04-12	U-1328		2013-02-15
N202278-001	8470853	2027-04-12	U-1328		2013-07-11
N202278-001	8597272	2027-04-12		Drug product	2013-12-09
N202278-001	9427578	2027-04-12	U-1328	Drug product	2016-09-15
N202278-001	9272137	2027-09-07		Drug product	2016-03-14
N202278-001	8366600	2029-04-21	U-1327		2013-02-15
N202278-001	8983594	2030-11-19	U-1328	Drug product	2015-04-08
N202278-001	9327114	2032-10-08	U-1328	Drug product	2016-05-26

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 · 43 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	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202278-001	ZECUITY	EQ 6.5MG BASE/4HR	SYSTEM / IONTOPHORESIS	RLD	2013-01-17	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 411 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N202278-001	7973058	2027-04-12	U-1328		2013-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202278-001	8155737	2027-04-12	U-1328		2013-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202278-001	8470853	2027-04-12	U-1328		2013-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202278-001	8597272	2027-04-12		Drug product	2013-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202278-001	9427578	2027-04-12	U-1328	Drug product	2016-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202278-001	9272137	2027-09-07		Drug product	2016-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202278-001	8366600	2029-04-21	U-1327		2013-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202278-001	8983594	2030-11-19	U-1328	Drug product	2015-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202278-001	9327114	2032-10-08	U-1328	Drug product	2016-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202278-001	7973058	2027-04-12	U-1328		2013-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202278-001	8155737	2027-04-12	U-1328		2013-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202278-001	8470853	2027-04-12	U-1328		2013-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202278-001	8597272	2027-04-12		Drug product	2013-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202278-001	9427578	2027-04-12	U-1328	Drug product	2016-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202278-001	9272137	2027-09-07		Drug product	2016-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202278-001	8366600	2029-04-21	U-1327		2013-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202278-001	8983594	2030-11-19	U-1328	Drug product	2015-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202278-001	9327114	2032-10-08	U-1328	Drug product	2016-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202278-001	7973058	2027-04-12	U-1328		2013-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202278-001	8155737	2027-04-12	U-1328		2013-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202278-001	8470853	2027-04-12	U-1328		2013-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202278-001	8597272	2027-04-12		Drug product	2013-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202278-001	9427578	2027-04-12	U-1328	Drug product	2016-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202278-001	9272137	2027-09-07		Drug product	2016-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202278-001	8366600	2029-04-21	U-1327		2013-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202278-001	8983594	2030-11-19	U-1328	Drug product	2015-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202278-001	9327114	2032-10-08	U-1328	Drug product	2016-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202278-001	7973058	2027-04-12	U-1328		2013-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202278-001	8155737	2027-04-12	U-1328		2013-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202278-001	8470853	2027-04-12	U-1328		2013-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202278-001	8597272	2027-04-12		Drug product	2013-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202278-001	9427578	2027-04-12	U-1328	Drug product	2016-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202278-001	9272137	2027-09-07		Drug product	2016-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202278-001	8366600	2029-04-21	U-1327		2013-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202278-001	8983594	2030-11-19	U-1328	Drug product	2015-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202278-001	9327114	2032-10-08	U-1328	Drug product	2016-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202278-001	7973058	2027-04-12	U-1328		2013-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202278-001	8155737	2027-04-12	U-1328		2013-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202278-001	8470853	2027-04-12	U-1328		2013-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202278-001	8597272	2027-04-12		Drug product	2013-12-09	`6a471c1ec25d…`

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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
40161	SUPPL	2014-03-25
32227	SUPPL	2014-03-25
32226	SUPPL	2014-03-25
19312	SUPPL	2014-03-25
43393	ORIG	2013-11-25
24413	ORIG	2013-11-25
40160	ORIG	2013-01-22
32225	ORIG	2013-01-22