Home Applications 204604 Application 204604
Type ANDA
Sponsor AMNEAL PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204604-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204604-001 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 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65162-732 Montelukast Sodium Montelukast Amneal Pharmaceuticals LLC ANDA Current 65162-732 Montelukast Sodium Montelukast Amneal Pharmaceuticals LLC ANDA Current 65162-732 Montelukast Sodium Montelukast Amneal Pharmaceuticals LLC ANDA Current 65162-732 Montelukast Sodium Montelukast Amneal Pharmaceuticals LLC ANDA Current 65162-732 Montelukast Sodium Montelukast Amneal Pharmaceuticals LLC ANDA Current 65162-732 Montelukast Sodium Montelukast Amneal Pharmaceuticals LLC ANDA Current 65162-732 Montelukast Sodium Montelukast Amneal Pharmaceuticals LLC ANDA Current