Home Applications 206787 Application 206787
Type ANDA
Sponsor AMNEAL PHARMS CO 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 A206787-001 ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 A206787-002 ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25
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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2018-05-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2018-05-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206787-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2018-05-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206787-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2018-05-25 bb7c543d1eb4…
Observed Orange Book normalized TE history# 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
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65162-042 Eletriptan Hydrobromide Eletriptan Hydrobromide Amneal Pharmaceuticals LLC ANDA Current 65162-042 Eletriptan Hydrobromide Eletriptan Hydrobromide Amneal Pharmaceuticals LLC ANDA Current 65162-042 Eletriptan Hydrobromide Eletriptan Hydrobromide Amneal Pharmaceuticals LLC ANDA Current 65162-042 Eletriptan Hydrobromide Eletriptan Hydrobromide Amneal Pharmaceuticals LLC ANDA Current 65162-042 Eletriptan Hydrobromide Eletriptan Hydrobromide Amneal Pharmaceuticals LLC ANDA Current 65162-043 Eletriptan Hydrobromide Eletriptan Hydrobromide Amneal Pharmaceuticals LLC ANDA Current 65162-043 Eletriptan Hydrobromide Eletriptan Hydrobromide Amneal Pharmaceuticals LLC ANDA Current 65162-043 Eletriptan Hydrobromide Eletriptan Hydrobromide Amneal Pharmaceuticals LLC ANDA Current 65162-043 Eletriptan Hydrobromide Eletriptan Hydrobromide Amneal Pharmaceuticals LLC ANDA Current 65162-043 Eletriptan Hydrobromide Eletriptan Hydrobromide Amneal Pharmaceuticals LLC ANDA Current