Application 206409

Type: ANDA
Sponsor: ZYDUS PHARMS

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 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
A206409-001	ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB		2017-06-16
A206409-002	ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB		2017-06-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206409-001	AB
A206409-002	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 3 · 84 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	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206409-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-06-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206409-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-06-16	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A206409-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206409-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206409-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206409-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206409-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206409-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206409-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206409-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206409-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206409-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206409-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206409-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206409-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206409-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206409-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206409-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206409-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206409-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206409-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206409-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206409-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206409-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206409-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206409-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206409-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206409-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206409-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206409-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206409-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206409-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206409-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206409-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206409-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206409-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206409-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206409-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206409-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206409-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206409-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206409-002	AB	1	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eletriptan hydrobromide	ELETRIPTAN HYDROBROMIDE	Bryant Ranch Prepack	7924b4fa-3e3d-4777-a59f-9320c6118196	2026-02-04		Exact identifier application applno (ANDA): 206409 application number: ANDA206409
Eletriptan hydrobromide	ELETRIPTAN HYDROBROMIDE	Zydus Lifesciences Limited	481ae7d4-9e57-424a-9d07-2920954b6ddc	2024-11-28		Exact identifier application applno (ANDA): 206409 application number: ANDA206409 ndc (product): 70771-1107 ndc (product): 70771-1108
Eletriptan hydrobromide	ELETRIPTAN HYDROBROMIDE	Zydus Pharmaceuticals USA Inc.	e0dfeb1f-f0f0-449a-81ae-2c8fdddcff10	2023-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206409 application number: ANDA206409 ndc (product): 68382-923 ndc (product): 68382-922

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-922	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-922	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-922	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-922	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-923	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-923	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-923	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-923	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1107	Eletriptan hydrobromide	Eletriptan hydrobromide	Cadila Healthcare Limited	ANDA	Current
70771-1107	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Lifesciences Limited	ANDA	Current
70771-1107	Eletriptan hydrobromide	Eletriptan hydrobromide	Cadila Healthcare Limited	ANDA	Current
70771-1107	Eletriptan hydrobromide	Eletriptan hydrobromide	Cadila Healthcare Limited	ANDA	Current
70771-1108	Eletriptan hydrobromide	Eletriptan hydrobromide	Cadila Healthcare Limited	ANDA	Current
70771-1108	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Lifesciences Limited	ANDA	Current
70771-1108	Eletriptan hydrobromide	Eletriptan hydrobromide	Cadila Healthcare Limited	ANDA	Current
70771-1108	Eletriptan hydrobromide	Eletriptan hydrobromide	Cadila Healthcare Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48782	ORIG	2017-06-20