Application 209680

Type: ANDA
Sponsor: YUNG SHIN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE	TABLET;ORAL	EQ 20MG BASE	No	No
002	ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE	TABLET;ORAL	EQ 40MG BASE	No	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
A209680-001	ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL			2020-07-13
A209680-002	ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL			2020-07-13

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 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209680-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2020-07-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209680-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2020-07-13	`bb7c543d1eb4…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eletriptan Hydrobromide	ELETRIPTAN HYDROBROMIDE	Apnar Pharma LP	49686c51-bbd9-45f0-92b1-8ffa81612e35	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Eletriptan Hydrobromide generic name: ELETRIPTAN HYDROBROMIDE
Eletriptan hydrobromide	ELETRIPTAN HYDROBROMIDE	Bryant Ranch Prepack	7924b4fa-3e3d-4777-a59f-9320c6118196	2026-02-04		Name fallback brand name: Eletriptan hydrobromide generic name: ELETRIPTAN HYDROBROMIDE
Eletriptan hydrobromide	ELETRIPTAN HYDROBROMIDE	Camber Pharmaceuticals, Inc.	6d412c0d-c8bd-498d-b57c-6626fb33147a	2025-08-30	Warnings, Adverse reactions	Name fallback brand name: Eletriptan hydrobromide generic name: ELETRIPTAN HYDROBROMIDE
Eletriptan hydrobromide	ELETRIPTAN HYDROBROMIDE	Zydus Lifesciences Limited	481ae7d4-9e57-424a-9d07-2920954b6ddc	2024-11-28		Name fallback brand name: Eletriptan hydrobromide generic name: ELETRIPTAN HYDROBROMIDE
Eletriptan Hydrobromide	ELETRIPTAN HYDROBROMIDE	Teva Pharmaceuticals USA, Inc.	62dc12ce-4f19-41c6-9593-3cae29f04af1	2024-11-27	Warnings, Adverse reactions	Name fallback brand name: Eletriptan Hydrobromide generic name: ELETRIPTAN HYDROBROMIDE
Eletriptan Hydrobromide	ELETRIPTAN HYDROBROMIDE	Bryant Ranch Prepack	a3953ca6-3da6-4420-9eb5-a16b38372f4e	2024-09-13	Warnings, Adverse reactions	Name fallback brand name: Eletriptan Hydrobromide generic name: ELETRIPTAN HYDROBROMIDE
Eletriptan Hydrobromide	ELETRIPTAN HYDROBROMIDE	Advanced Rx of Tennessee, LLC	1bbcb13f-d1cb-82c1-e063-6394a90a7753	2024-06-25	Warnings, Adverse reactions	Name fallback brand name: Eletriptan Hydrobromide generic name: ELETRIPTAN HYDROBROMIDE
Eletriptan Hydrobromide	ELETRIPTAN HYDROBROMIDE	Aurobindo Pharma Limited	bb5ea5df-4add-420d-88cb-6dabe116ca65	2024-06-03	Warnings, Adverse reactions	Name fallback brand name: Eletriptan Hydrobromide generic name: ELETRIPTAN HYDROBROMIDE
Relpax	ELETRIPTAN HYDROBROMIDE	Viatris Specialty LLC	2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e	2024-01-15	Warnings, Adverse reactions	Name fallback generic name: ELETRIPTAN HYDROBROMIDE
Eletriptan hydrobromide	ELETRIPTAN HYDROBROMIDE	Zydus Pharmaceuticals USA Inc.	e0dfeb1f-f0f0-449a-81ae-2c8fdddcff10	2023-09-18	Warnings, Adverse reactions	Name fallback brand name: Eletriptan hydrobromide generic name: ELETRIPTAN HYDROBROMIDE
Eletriptan Hydrobromide	ELETRIPTAN HYDROBROMIDE	Mylan Pharmaceuticals Inc.	20276f5c-f2d6-469f-9a1b-aa254a1db21c	2020-04-15	Warnings, Adverse reactions	Name fallback brand name: Eletriptan Hydrobromide generic name: ELETRIPTAN HYDROBROMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.