Home Applications 021001 Application 021001
Type NDA
Sponsor JANSSEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AXERT ALMOTRIPTAN MALATE TABLET;ORAL EQ 6.25MG BASE Yes No 002 AXERT ALMOTRIPTAN MALATE TABLET;ORAL EQ 12.5MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N021001-001 AXERT ALMOTRIPTAN MALATE EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 N021001-002 AXERT ALMOTRIPTAN MALATE EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07
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 2 of 3 · 88 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 2019-12-13 00:20 UTC 2019-12 N021001-001 AXERT EQ 6.25MG BASE TABLET / ORAL RLD 2001-05-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021001-002 AXERT EQ 12.5MG BASE TABLET / ORAL RLD 2001-05-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021001-001 AXERT EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021001-002 AXERT EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021001-001 AXERT EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 2001-05-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021001-002 AXERT EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 2001-05-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021001-001 AXERT EQ 6.25MG BASE TABLET / ORAL RLD 2001-05-07 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021001-002 AXERT EQ 12.5MG BASE TABLET / ORAL RLD 2001-05-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021001-001 AXERT EQ 6.25MG BASE TABLET / ORAL RLD 2001-05-07 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021001-002 AXERT EQ 12.5MG BASE TABLET / ORAL RLD 2001-05-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021001-001 AXERT EQ 6.25MG BASE TABLET / ORAL RLD 2001-05-07 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021001-002 AXERT EQ 12.5MG BASE TABLET / ORAL RLD 2001-05-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021001-001 AXERT EQ 6.25MG BASE TABLET / ORAL RLD 2001-05-07 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021001-002 AXERT EQ 12.5MG BASE TABLET / ORAL RLD 2001-05-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021001-001 AXERT EQ 6.25MG BASE TABLET / ORAL RLD 2001-05-07 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021001-002 AXERT EQ 12.5MG BASE TABLET / ORAL RLD 2001-05-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021001-001 AXERT EQ 6.25MG BASE TABLET / ORAL AB RLD 2001-05-07 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021001-002 AXERT EQ 12.5MG BASE TABLET / ORAL AB RLD, RS 2001-05-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021001-001 AXERT EQ 6.25MG BASE TABLET / ORAL AB RLD 2001-05-07 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021001-002 AXERT EQ 12.5MG BASE TABLET / ORAL AB RLD, RS 2001-05-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021001-001 AXERT EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021001-002 AXERT EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021001-001 AXERT EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N021001-002 AXERT EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021001-001 AXERT EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N021001-002 AXERT EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021001-001 AXERT EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021001-002 AXERT EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021001-001 AXERT EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021001-002 AXERT EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021001-001 AXERT EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021001-002 AXERT EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021001-001 AXERT EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021001-002 AXERT EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021001-001 AXERT EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N021001-002 AXERT EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021001-001 AXERT EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N021001-002 AXERT EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021001-001 AXERT EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021001-002 AXERT EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-05-07 3a93d1ddd44b…
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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50458-210 AXERT almotriptan malate Janssen Pharmaceuticals, Inc. NDA Current 50458-210 AXERT almotriptan malate Janssen Pharmaceuticals, Inc. NDA Current 50458-210 AXERT almotriptan malate Janssen Pharmaceuticals, Inc. NDA Current 50458-211 AXERT almotriptan malate Janssen Pharmaceuticals, Inc. NDA Current 50458-211 AXERT almotriptan malate Janssen Pharmaceuticals, Inc. NDA Current 50458-211 AXERT almotriptan malate Janssen Pharmaceuticals, Inc. NDA Current