Home Applications 201522 Application 201522
Type ANDA
Sponsor LANNETT CO INC 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 A201522-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201522-001 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 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201522-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 19 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42254-263 Montelukast Sodium Montelukast Sodium Rebel Distributors Corp ANDA Current 42291-621 Montelukast Sodium Montelukast Sodium AvKARE, Inc. ANDA Current 42291-621 Montelukast Sodium Montelukast Sodium AvKARE, Inc. ANDA Current 42291-621 Montelukast Sodium Montelukast Sodium AvKARE ANDA Current 42291-621 Montelukast Sodium Montelukast Sodium AvKARE ANDA Current 43353-879 Montelukast Sodium Montelukast Sodium Aphena Pharma Solutions - Tennessee, LLC ANDA Current 50268-575 Montelukast Sodium Montelukast Sodium AvPAK ANDA Current 50268-575 Montelukast Sodium Montelukast Sodium AvPAK ANDA Current 50268-575 Montelukast Sodium Montelukast Sodium AvPAK ANDA Current 62175-210 Montelukast Sodium Montelukast Sodium Lannett Company, Inc. ANDA Current 62175-210 Montelukast Sodium Montelukast Sodium Lannett Company, Inc. ANDA Current 62175-210 Montelukast Sodium Montelukast Sodium Lannett Company, Inc. ANDA Current 62175-210 Montelukast Sodium Montelukast Sodium Lannett Company, Inc.. ANDA Current 62175-210 Montelukast Sodium Montelukast Sodium Lannett Company, Inc. ANDA Current 62175-210 Montelukast Sodium Montelukast Sodium Lannett Company, Inc. ANDA Current 63187-216 Montelukast Sodium Montelukast Sodium Proficient Rx LP ANDA Current 63187-216 Montelukast Sodium Montelukast Sodium Proficient Rx LP ANDA Current 70518-1075 Montelukast Sodium Montelukast Sodium REMEDYREPACK INC. ANDA Current 70518-1075 Montelukast Sodium Montelukast Sodium REMEDYREPACK INC. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 32114 ORIG 2012-08-06