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 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 3 of 3 · 50 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join montelukast sodium MONTELUKAST SODIUM Proficient Rx LP 2ce48faf-4504-488a-8b20-3e8d4f008fb2 2022-06-01 Warnings, Adverse reactions Name fallback brand name: montelukast sodium generic name: MONTELUKAST SODIUM Montelukast Sodium MONTELUKAST SODIUM Proficient Rx LP 97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e5 2022-05-02 Warnings, Adverse reactions Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM Montelukast Sodium MONTELUKAST SODIUM Accord Healthcare Inc. 6eea668f-a2fa-447f-b2d5-4c754d13d9fa 2022-01-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM Montelukast Sodium MONTELUKAST SODIUM Proficient Rx LP 83c35a3d-0bbc-4598-bf76-ab0c2903bf19 2021-07-01 Warnings, Adverse reactions Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM montelukast sodium MONTELUKAST SODIUM Camber Pharmaceuticals, Inc. 23964723-2df8-4d0a-a53d-8538469672f1 2021-06-18 Boxed warning, Warnings, Adverse reactions Name fallback brand name: montelukast sodium generic name: MONTELUKAST SODIUM MONTELUKAST SODIUM MONTELUKAST SODIUM Proficient Rx LP 901385e5-7384-4c28-a36a-7dd84c36f5fd 2021-01-01 Warnings, Adverse reactions Name fallback brand name: MONTELUKAST SODIUM generic name: MONTELUKAST SODIUM MONTELUKAST SODIUM MONTELUKAST SODIUM Proficient Rx LP 54014b67-3163-4c8f-b93a-229cd231ca6b 2021-01-01 Warnings, Adverse reactions Name fallback brand name: MONTELUKAST SODIUM generic name: MONTELUKAST SODIUM Montelukast Sodium MONTELUKAST SODIUM Proficient Rx LP 8a724790-e1fb-4935-bb28-ce99455be5ef 2019-11-01 Warnings, Adverse reactions Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM Montelukast Sodium MONTELUKAST SODIUM Proficient Rx LP 0f2dbf17-bce0-4e09-8c22-898d93be80da 2019-11-01 Warnings, Adverse reactions Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM MONTELUKAST SODIUM MONTELUKAST Proficient Rx LP cab84c43-96a3-4868-88da-3126685edf00 2019-10-01 Warnings, Adverse reactions Name fallback brand name: MONTELUKAST SODIUM
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 · 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