Home Applications 090381 Application 090381
Type ANDA
Sponsor HIKMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NARATRIPTAN NARATRIPTAN HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE No No 002 NARATRIPTAN NARATRIPTAN HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A090381-001 NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2010-07-07 A090381-002 NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0054-0278 Naratriptan Naratriptan Hikma Pharmaceuticals USA Inc. ANDA Current 0054-0278 Naratriptan Naratriptan West-Ward Pharmaceuticals Corp. ANDA Current 0054-0279 Naratriptan Naratriptan Hikma Pharmaceuticals USA Inc. ANDA Current 0054-0279 Naratriptan Naratriptan West-Ward Pharmaceuticals Corp. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 31465 ORIG 2010-07-09