Application 213998

Type: ANDA
Sponsor: CAPLIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	INJECTABLE;SUBCUTANEOUS	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	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
A213998-001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP		2021-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213998-001	AP

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	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`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	A213998-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213998-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213998-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213998-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213998-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213998-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213998-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213998-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213998-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213998-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213998-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213998-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213998-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213998-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213998-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213998-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213998-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213998-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213998-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213998-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213998-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213998-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213998-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213998-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213998-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213998-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213998-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213998-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213998-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213998-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213998-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213998-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213998-001	AP	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sumatriptan	SUMATRIPTAN	Armas Pharmaceuticals Inc.	65147b04-0b6b-4d30-9710-d5cdce85e8f5	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213998 application number: ANDA213998
Sumatriptan	SUMATRIPTAN	A-S Medication Solutions	7f34f450-d6f3-49a8-b55a-8e1e4a9ee950	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213998 application number: ANDA213998
Sumatriptan	SUMATRIPTAN	Caplin Steriles Limited	01293e09-d49a-411d-9647-6f23318ac201	2024-09-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213998 application number: ANDA213998 ndc (product): 65145-118
Sumatriptan	SUMATRIPTAN SUCCINATE	Xellia Pharmaceuticals USA LLC	f42c6e00-e693-48f3-8e84-c3f139e1adf5	2021-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213998 application number: ANDA213998 ndc (product): 70594-068
Sumatriptan	SUMATRIPTAN	Somerset Therapeutics, LLC	53c62307-bd19-4418-b1b0-c0274b5595df	2021-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213998 application number: ANDA213998 ndc (product): 70069-804

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
65145-118	Sumatriptan	Sumatriptan	Caplin Steriles Limited	ANDA	Current
70069-804	Sumatriptan	Sumatriptan	Somerset Therapeutics, LLC	ANDA	Current
70594-068	Sumatriptan	SUMATRIPTAN SUCCINATE	Xellia Pharmaceuticals USA LLC	ANDA	Current