Home Applications 021016 Application 021016
Type NDA
Sponsor PFIZER IRELAND Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RELPAX ELETRIPTAN HYDROBROMIDE TABLET;ORAL EQ 20MG BASE Yes No 002 RELPAX ELETRIPTAN HYDROBROMIDE TABLET;ORAL EQ 40MG BASE Yes Yes
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 N021016-001 RELPAX ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 N021016-002 RELPAX ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Relpax ELETRIPTAN HYDROBROMIDE Viatris Specialty LLC 2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e 2024-01-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 021016 application number: NDA021016
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 23 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0049-2330 Relpax eletriptan hydrobromide Roerig NDA Current 0049-2330 Relpax eletriptan hydrobromide Roerig NDA Current 0049-2330 Relpax eletriptan hydrobromide Roerig NDA Current 0049-2330 Relpax eletriptan hydrobromide Roerig NDA Current 0049-2330 Relpax eletriptan hydrobromide Roerig NDA Current 0049-2340 Relpax eletriptan hydrobromide Roerig NDA Current 0049-2340 Relpax eletriptan hydrobromide Roerig NDA Current 0049-2340 Relpax eletriptan hydrobromide Roerig NDA Current 0049-2340 Relpax eletriptan hydrobromide Roerig NDA Current 0049-2340 Relpax eletriptan hydrobromide Roerig NDA Current 21695-871 Relpax eletriptan hydrobromide Rebel Distributors Corp NDA Current 59762-2321 Eletriptan eletriptan hydrobromide Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-2321 Eletriptan eletriptan hydrobromide Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-2321 Eletriptan eletriptan hydrobromide Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-2321 Eletriptan eletriptan hydrobromide Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-2321 Eletriptan eletriptan hydrobromide Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-2322 Eletriptan eletriptan hydrobromide Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-2322 Eletriptan eletriptan hydrobromide Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-2322 Eletriptan eletriptan hydrobromide Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-2322 Eletriptan eletriptan hydrobromide Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-2322 Eletriptan eletriptan hydrobromide Greenstone LLC NDA AUTHORIZED GENERIC Current 63539-234 Relpax eletriptan hydrobromide U.S. Pharmaceuticals NDA Current 63539-234 Relpax eletriptan hydrobromide U.S. Pharmaceuticals NDA Current