Home Applications 201536 Application 201536
Type ANDA
Sponsor APOTEX INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE TABLET; ORAL 20MG No No 002 ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE TABLET; ORAL 40MG No No
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openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
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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