Application 213465

Type: ANDA
Sponsor: PERRIGO UK FINCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUMATRIPTAN	SUMATRIPTAN	SPRAY;NASAL	20MG/SPRAY	No	No
002	SUMATRIPTAN	SUMATRIPTAN SUCCINATE	SPRAY;NASAL	5MG/SPRAY	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A213465-001	SUMATRIPTAN	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB		2020-09-21
A213465-002	SUMATRIPTAN	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB		2020-09-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213465-001	AB
A213465-002	AB

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 · 73 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213465-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213465-002	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	2020-09-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 73 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213465-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213465-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213465-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213465-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213465-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213465-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213465-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213465-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213465-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213465-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213465-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213465-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213465-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213465-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213465-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213465-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213465-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213465-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213465-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213465-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213465-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213465-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213465-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213465-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213465-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213465-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213465-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213465-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213465-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213465-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213465-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213465-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213465-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213465-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213465-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213465-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213465-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213465-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213465-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213465-002	AB	1	`782e0a99824c…`

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
SUMATRIPTAN	SUMATRIPTAN	Bryant Ranch Prepack	7328ab4f-2985-448d-8724-8f1b55693b41	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213465 application number: ANDA213465 ndc (product): 63629-8703
SUMATRIPTAN	SUMATRIPTAN	Padagis Israel Pharmaceuticals Ltd	6d521807-e5ce-498d-a224-5534c5ea61fa	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213465 application number: ANDA213465 ndc (product): 45802-598 ndc (product): 45802-619

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-598	SUMATRIPTAN	sumatriptan	Perrigo New York Inc	ANDA	Current
45802-598	SUMATRIPTAN	sumatriptan	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-598	SUMATRIPTAN	sumatriptan	Perrigo New York Inc	ANDA	Current
45802-619	SUMATRIPTAN	sumatriptan	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-619	SUMATRIPTAN	sumatriptan	Perrigo New York Inc	ANDA	Current
63629-8703	SUMATRIPTAN	sumatriptan	Bryant Ranch Prepack	ANDA	Current
63629-8703	SUMATRIPTAN	sumatriptan	Bryant Ranch Prepack	ANDA	Current
63629-8703	SUMATRIPTAN	sumatriptan	Bryant Ranch Prepack	ANDA	Current