Home Applications 202096 Application 202096
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET, CHEWABLE;ORAL EQ 4MG BASE No No 002 MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET, CHEWABLE;ORAL EQ 5MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202096-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 A202096-002 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 88 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 2026-10-15 13:18:30 2026-09 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202096-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202096-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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.
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 · 33 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50090-2619 Montelukast Sodium Montelukast Sodium A-S Medication Solutions ANDA Current 52343-035 Montelukast Sodium Montelukast Sodium ACETRIS HEALTH, LLC ANDA Current 52343-035 Montelukast Sodium Montelukast Sodium ACETRIS HEALTH, LLC ANDA Current 52343-036 Montelukast Sodium Montelukast Sodium ACETRIS HEALTH, LLC ANDA Current 52343-036 Montelukast Sodium Montelukast Sodium ACETRIS HEALTH, LLC ANDA Current 53002-4730 Montelukast Sodium Montelukast Sodium RPK Pharmaceuticals, Inc. ANDA Current 57237-212 Montelukast Sodium Montelukast Sodium Rising Health, LLC ANDA Current 57237-212 Montelukast Sodium Montelukast Sodium Rising Health, LLC ANDA Current 57237-212 Montelukast Sodium Montelukast Sodium Rising Health, LLC ANDA Current 57237-212 Montelukast Sodium Montelukast Sodium Rising Health, LLC ANDA Current 57237-212 Montelukast Sodium Montelukast Sodium Rising Health, LLC ANDA Current 57237-213 Montelukast Sodium Montelukast Sodium Rising Health, LLC ANDA Current 57237-213 Montelukast Sodium Montelukast Sodium Rising Health, LLC ANDA Current 57237-213 Montelukast Sodium Montelukast Sodium Rising Health, LLC ANDA Current 57237-213 Montelukast Sodium Montelukast Sodium Rising Health, LLC ANDA Current 57237-213 Montelukast Sodium Montelukast Sodium Rising Health, LLC ANDA Current 63629-4978 Montelukast Sodium Montelukast Sodium Bryant Ranch Prepack ANDA Current 63629-4978 Montelukast Sodium Montelukast Sodium Bryant Ranch Prepack ANDA Current 65862-567 Montelukast Sodium Montelukast Sodium Aurobindo Pharma Limited ANDA Current 65862-567 Montelukast Sodium Montelukast Sodium Aurobindo Pharma Limited ANDA Current 65862-567 Montelukast Sodium Montelukast Sodium Aurobindo Pharma Limited ANDA Current 65862-567 Montelukast Sodium Montelukast Sodium Aurobindo Pharma Limited ANDA Current 65862-567 Montelukast Sodium Montelukast Sodium Aurobindo Pharma Limited ANDA Current 65862-567 Montelukast Sodium Montelukast Sodium Aurobindo Pharma Limited ANDA Current 65862-568 Montelukast Sodium Montelukast Sodium Aurobindo Pharma Limited ANDA Current 65862-568 Montelukast Sodium Montelukast Sodium Aurobindo Pharma Limited ANDA Current 65862-568 Montelukast Sodium Montelukast Sodium Aurobindo Pharma Limited ANDA Current 65862-568 Montelukast Sodium Montelukast Sodium Aurobindo Pharma Limited ANDA Current 65862-568 Montelukast Sodium Montelukast Sodium Aurobindo Pharma Limited ANDA Current 65862-568 Montelukast Sodium Montelukast Sodium Aurobindo Pharma Limited ANDA Current 68788-6410 Montelukast Sodium Montelukast Sodium Preferred Pharmaceuticals Inc. ANDA Current 71610-026 Montelukast Sodium Montelukast Sodium Aphena Pharma Solutions - Tennessee, LLC ANDA Current 71610-026 Montelukast Sodium Montelukast Sodium Aphena Pharma Solutions - Tennessee, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 32174 ORIG 2012-08-06