Application 203366

Type: ANDA
Sponsor: MACLEODS PHARMS 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 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
A203366-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB		2014-09-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A203366-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203366-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203366-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203366-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203366-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203366-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203366-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203366-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203366-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203366-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203366-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203366-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203366-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203366-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203366-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203366-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203366-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203366-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203366-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203366-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203366-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203366-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203366-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203366-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203366-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203366-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203366-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203366-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203366-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203366-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203366-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203366-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203366-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203366-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203366-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203366-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203366-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203366-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203366-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203366-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203366-001	AB	1	`cb3db0bc1861…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Montelukast	MONTELUKAST	Coupler LLC	583a9499-97f0-2ebf-e063-6394a90a35af	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203366 application number: ANDA203366
Montelukast	MONTELUKAST	NuCare Pharmaceuticals, Inc.	365e1c5c-01b2-bf4e-e063-6394a90a0e43	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203366 application number: ANDA203366
Montelukast	MONTELUKAST	NuCare Pharmaceuticals,Inc.	56429f04-97b6-06a9-e054-00144ff88e88	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203366 application number: ANDA203366 ndc (product): 68071-4034
Montelukast	MONTELUKAST	Macleods Pharmaceuticals Limited	e0c5b856-3f70-4ca6-9763-a90673bb82fb	2023-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203366 application number: ANDA203366 ndc (product): 33342-102
Montelukast	MONTELUKAST	BluePoint Laboratories	4c411d3e-47b6-481b-b846-419ed4cbb947	2022-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203366 application number: ANDA203366 ndc (product): 68001-361

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-102	Montelukast	Montelukast	Macleods Pharmaceuticals Limited	ANDA	Current
33342-102	Montelukast	Montelukast	Macleods Pharmaceuticals Limited	ANDA	Current
33342-102	Montelukast	Montelukast	Macleods Pharmaceuticals Limited	ANDA	Current
33342-102	Montelukast	Montelukast	Macleods Pharmaceuticals Limited	ANDA	Current
33342-102	Montelukast	Montelukast	Macleods Pharmaceuticals Limited	ANDA	Current
68001-361	Montelukast	Montelukast	BluePoint Laboratories	ANDA	Current
68001-361	Montelukast	Montelukast	BluePoint Laboratories	ANDA	Current
68001-361	Montelukast	Montelukast	BluePoint Laboratories	ANDA	Current
68001-361	Montelukast	Montelukast	BluePoint Laboratories	ANDA	Current
68001-361	Montelukast	Montelukast	BluePoint Laboratories	ANDA	Current
68001-361	Montelukast	Montelukast	BluePoint Laboratories	ANDA	Current
68071-4034	Montelukast	Montelukast	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4034	Montelukast	Montelukast	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-1031	Montelukast	Montelukast	REMEDYREPACK INC.	ANDA	Current
70518-1031	Montelukast	Montelukast	REMEDYREPACK INC.	ANDA	Current
70518-2603	Montelukast	Montelukast	REMEDYREPACK INC.	ANDA	Current
70518-2603	Montelukast	Montelukast	REMEDYREPACK INC.	ANDA	Current
70518-2603	Montelukast	Montelukast	REMEDYREPACK INC.	ANDA	Current