Home Applications 020132 Application 020132
Type NDA
Sponsor GLAXOSMITHKLINE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IMITREX SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 100MG BASE Yes Yes 002 IMITREX SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 25MG BASE Yes No 003 IMITREX SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 50MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020132-001 IMITREX SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB RLD, RS 1995-06-01 N020132-002 IMITREX SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB RLD 1995-06-01 N020132-003 IMITREX SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB RLD 1995-06-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 N020132-001 IMITREX EQ 100MG BASE TABLET / ORAL AB RLD, RS 1995-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020132-002 IMITREX EQ 25MG BASE TABLET / ORAL AB RLD 1995-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020132-003 IMITREX EQ 50MG BASE TABLET / ORAL AB RLD 1995-06-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020132-001 IMITREX EQ 100MG BASE TABLET / ORAL AB RLD, RS 1995-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020132-002 IMITREX EQ 25MG BASE TABLET / ORAL AB RLD 1995-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020132-003 IMITREX EQ 50MG BASE TABLET / ORAL AB RLD 1995-06-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020132-001 IMITREX EQ 100MG BASE TABLET / ORAL AB RLD, RS 1995-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020132-002 IMITREX EQ 25MG BASE TABLET / ORAL AB RLD 1995-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020132-003 IMITREX EQ 50MG BASE TABLET / ORAL AB RLD 1995-06-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020132-001 IMITREX EQ 100MG BASE TABLET / ORAL AB RLD, RS 1995-06-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020132-002 IMITREX EQ 25MG BASE TABLET / ORAL AB RLD 1995-06-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020132-003 IMITREX EQ 50MG BASE TABLET / ORAL AB RLD 1995-06-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020132-001 IMITREX EQ 100MG BASE TABLET / ORAL AB RLD, RS 1995-06-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020132-002 IMITREX EQ 25MG BASE TABLET / ORAL AB RLD 1995-06-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020132-003 IMITREX EQ 50MG BASE TABLET / ORAL AB RLD 1995-06-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020132-001 IMITREX EQ 100MG BASE TABLET / ORAL AB RLD, RS 1995-06-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020132-002 IMITREX EQ 25MG BASE TABLET / ORAL AB RLD 1995-06-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020132-003 IMITREX EQ 50MG BASE TABLET / ORAL AB RLD 1995-06-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020132-001 IMITREX EQ 100MG BASE TABLET / ORAL AB RLD, RS 1995-06-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020132-002 IMITREX EQ 25MG BASE TABLET / ORAL AB RLD 1995-06-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020132-003 IMITREX EQ 50MG BASE TABLET / ORAL AB RLD 1995-06-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020132-001 IMITREX EQ 100MG BASE TABLET / ORAL AB RLD, RS 1995-06-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020132-002 IMITREX EQ 25MG BASE TABLET / ORAL AB RLD 1995-06-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020132-003 IMITREX EQ 50MG BASE TABLET / ORAL AB RLD 1995-06-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020132-001 IMITREX EQ 100MG BASE TABLET / ORAL AB RLD, RS 1995-06-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020132-002 IMITREX EQ 25MG BASE TABLET / ORAL AB RLD 1995-06-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020132-003 IMITREX EQ 50MG BASE TABLET / ORAL AB RLD 1995-06-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020132-001 IMITREX EQ 100MG BASE TABLET / ORAL AB RLD, RS 1995-06-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020132-002 IMITREX EQ 25MG BASE TABLET / ORAL AB RLD 1995-06-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020132-003 IMITREX EQ 50MG BASE TABLET / ORAL AB RLD 1995-06-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020132-001 IMITREX EQ 100MG BASE TABLET / ORAL AB RLD, RS 1995-06-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020132-002 IMITREX EQ 25MG BASE TABLET / ORAL AB RLD 1995-06-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020132-003 IMITREX EQ 50MG BASE TABLET / ORAL AB RLD 1995-06-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020132-001 IMITREX EQ 100MG BASE TABLET / ORAL AB RLD, RS 1995-06-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020132-002 IMITREX EQ 25MG BASE TABLET / ORAL AB RLD 1995-06-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020132-003 IMITREX EQ 50MG BASE TABLET / ORAL AB RLD 1995-06-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020132-001 IMITREX EQ 100MG BASE TABLET / ORAL AB RLD, RS 1995-06-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020132-002 IMITREX EQ 25MG BASE TABLET / ORAL AB RLD 1995-06-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020132-003 IMITREX EQ 50MG BASE TABLET / ORAL AB RLD 1995-06-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020132-001 IMITREX EQ 100MG BASE TABLET / ORAL AB RLD, RS 1995-06-01 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 · 21 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0173-0735 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0735 IMITREX sumatriptan succinate GlaxoSmithKline LLC NDA Current 0173-0735 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0735 IMITREX sumatriptan succinate GlaxoSmithKline LLC NDA Current 0173-0735 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0735 IMITREX sumatriptan succinate GlaxoSmithKline LLC NDA Current 0173-0736 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0736 IMITREX sumatriptan succinate GlaxoSmithKline LLC NDA Current 0173-0736 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0736 IMITREX sumatriptan succinate GlaxoSmithKline LLC NDA Current 0173-0736 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0736 IMITREX sumatriptan succinate GlaxoSmithKline LLC NDA Current 0173-0737 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0737 IMITREX sumatriptan succinate GlaxoSmithKline LLC NDA Current 0173-0737 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0737 IMITREX sumatriptan succinate GlaxoSmithKline LLC NDA Current 0173-0737 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0737 IMITREX sumatriptan succinate GlaxoSmithKline LLC NDA Current 21695-154 IMITREX sumatriptan succinate Rebel Distributors Corp NDA Current 68258-3008 SUMATRIPTAN SUCCINATE sumatriptan succinate Dispensing Solutions Inc. NDA Current 68258-3009 SUMATRIPTAN SUCCINATE sumatriptan succinate Dispensing Solutions Inc. NDA Current