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
Source provenance: Browse the complete Orange Book source catalog .
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 ยท 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.