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 42.

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.

Application-product, TE code table
Application-product	TE code
A202096-001	AB
A202096-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
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…`
2019-12-13 00:20 UTC	2019-12	A202096-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202096-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202096-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202096-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202096-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202096-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202096-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202096-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202096-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202096-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202096-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202096-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202096-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202096-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202096-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202096-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202096-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202096-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202096-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202096-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202096-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202096-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202096-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202096-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202096-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202096-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202096-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202096-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202096-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202096-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202096-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202096-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202096-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202096-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202096-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202096-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202096-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202096-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202096-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202096-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202096-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202096-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202096-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202096-002	AB	1	`bb7c543d1eb4…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Montelukast Sodium	MONTELUKAST SODIUM	Rising Pharma Holdings, Inc.	49669ac0-0bb5-4576-bed5-9e85e0d76a44	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202096 application number: ANDA202096 ndc (product): 57237-213 ndc (product): 57237-212
Montelukast Sodium	MONTELUKAST SODIUM	Aurobindo Pharma Limited	ba42b0a9-83f1-4283-a853-f99cdd0761b9	2024-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202096 application number: ANDA202096 ndc (product): 65862-568 ndc (product): 65862-567

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