Home Applications 020148 Application 020148
Type NDA
Sponsor BAUSCH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MIGRANAL DIHYDROERGOTAMINE MESYLATE SPRAY, METERED;NASAL 0.5MG/SPRAY Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020148-001 MIGRANAL DIHYDROERGOTAMINE MESYLATE 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020148-001 AB
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 2 · 41 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 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL RLD, RS 1997-12-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL RLD, RS 1997-12-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL RLD, RS 1997-12-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL RLD, RS 1997-12-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 cb3db0bc1861…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0187-0245 Migranal dihydroergotamine mesylate Valeant Pharmaceuticals North America LLC NDA Current 0187-0245 Migranal dihydroergotamine mesylate Bausch Health US, LLC NDA Current 0187-0245 Migranal dihydroergotamine mesylate Bausch Health US, LLC NDA Current 0187-0245 Migranal dihydroergotamine mesylate Bausch Health US, LLC NDA Current 0187-0245 Migranal dihydroergotamine mesylate Valeant Pharmaceuticals North America LLC NDA Current 0187-0245 Migranal dihydroergotamine mesylate Bausch Health US, LLC NDA Current 0187-0245 Migranal dihydroergotamine mesylate Bausch Health US, LLC NDA Current 68682-357 Dihydroergotamine Mesylate dihydroergotamine mesylate Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-357 Dihydroergotamine Mesylate dihydroergotamine mesylate Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-357 Dihydroergotamine Mesylate dihydroergotamine mesylate Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-357 Dihydroergotamine Mesylate dihydroergotamine mesylate Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 71043 SUPPL 2022-05-11 71030 SUPPL 2022-05-10 59974 SUPPL 2019-09-11 59563 SUPPL 2019-08-02 41156 ORIG 2010-05-25 34298 SUPPL 2002-07-31 21209 SUPPL 2002-07-31 12250 SUPPL 2002-07-31 2065 SUPPL 2002-07-31