Application 208967

Type: ANDA
Sponsor: ICON CLINICAL RES

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A208967-001	SUMATRIPTAN	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB		2021-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208967-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208967-001	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	2021-02-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208967-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208967-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208967-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208967-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208967-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208967-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208967-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208967-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208967-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208967-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208967-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208967-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208967-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208967-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208967-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208967-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208967-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208967-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208967-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208967-001	AB	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208967-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208967-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208967-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208967-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208967-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208967-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208967-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208967-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208967-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208967-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208967-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208967-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208967-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208967-001	AB	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sumatriptan	SUMATRIPTAN	Florida Pharmaceutical Products, LLC.	267dadc1-6960-4d8b-88ef-86be9c5f7159	2021-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208967 application number: ANDA208967 ndc (product): 71921-170

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71921-170	Sumatriptan	sumatriptan	Florida Pharmaceutical Products, LLC.	ANDA	Current
71921-170	Sumatriptan	sumatriptan	Florida Pharmaceutical Products, LLC.	ANDA	Current