Application 202468

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;ORAL	EQ 10MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202468-001	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
A202468-001	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 · 42 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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202468-001	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	A202468-001	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	A202468-001	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	A202468-001	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	A202468-001	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	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202468-001	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	A202468-001	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	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202468-001	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	A202468-001	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	A202468-001	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	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A202468-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202468-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202468-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202468-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202468-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202468-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202468-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202468-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202468-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202468-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202468-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202468-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202468-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202468-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202468-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202468-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202468-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202468-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202468-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202468-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202468-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202468-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202468-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202468-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202468-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202468-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202468-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202468-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202468-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202468-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202468-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202468-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202468-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202468-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202468-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202468-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202468-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202468-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202468-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202468-001	AB	1	`e64feba35796…`

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 · 4 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): 202468 application number: ANDA202468 ndc (product): 57237-255
Montelukast Sodium	MONTELUKAST SODIUM	PD-Rx Pharmaceuticals, Inc.	6ffff72c-8784-477b-8722-5434a19881a0	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202468 application number: ANDA202468
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): 202468 application number: ANDA202468 ndc (product): 65862-574
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	461f2aaa-e091-478e-97c1-27a089db8cdc	2023-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202468 application number: ANDA202468

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52343-037	Montelukast Sodium	Montelukast Sodium	ACETRIS HEALTH, LLC	ANDA	Current
52343-037	Montelukast Sodium	Montelukast Sodium	ACETRIS HEALTH, LLC	ANDA	Current
53808-0920	Montelukast Sodium	Montelukast Sodium	State of Florida DOH Central Pharmacy	ANDA	Current
57237-255	Montelukast Sodium	Montelukast Sodium	Rising Health, LLC	ANDA	Current
57237-255	Montelukast Sodium	Montelukast Sodium	Rising Health, LLC	ANDA	Current
57237-255	Montelukast Sodium	Montelukast Sodium	Rising Health, LLC	ANDA	Current
57237-255	Montelukast Sodium	Montelukast Sodium	Rising Health, LLC	ANDA	Current
57237-255	Montelukast Sodium	Montelukast Sodium	Rising Health, LLC	ANDA	Current
65862-574	Montelukast Sodium	Montelukast Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-574	Montelukast Sodium	Montelukast Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-574	Montelukast Sodium	Montelukast Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-574	Montelukast Sodium	Montelukast Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-574	Montelukast Sodium	Montelukast Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-574	Montelukast Sodium	Montelukast Sodium	Aurobindo Pharma Limited	ANDA	Current
71610-129	Montelukast Sodium	Montelukast Sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10057	ORIG	2012-08-06