Application 201582

Type: ANDA
Sponsor: DR REDDYS LABS 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
A201582-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB		2012-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201582-001	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	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201582-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-06	`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	A201582-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201582-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201582-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201582-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201582-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201582-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201582-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201582-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201582-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201582-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201582-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201582-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201582-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201582-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201582-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201582-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201582-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201582-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201582-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201582-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201582-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201582-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201582-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201582-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201582-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201582-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201582-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201582-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201582-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201582-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201582-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201582-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201582-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201582-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201582-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201582-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201582-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201582-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201582-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201582-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Montelukast Sodium	MONTELUKAST SODIUM	American Health Packaging	fb1b2e4e-a840-447b-b943-ad0b6acc32b5	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201582 application number: ANDA201582 ndc (product): 68084-875
Montelukast Sodium	MONTELUKAST SODIUM	Dr.Reddy's Laboratories Limited	3d4451a9-d73d-b9de-68ec-853bfeff6e4b	2022-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201582 application number: ANDA201582 ndc (product): 55111-725

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
55111-725	Montelukast Sodium	Montelukast Sodium	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-725	Montelukast Sodium	Montelukast Sodium	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-725	Montelukast Sodium	Montelukast Sodium	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-725	Montelukast Sodium	Montelukast Sodium	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-725	Montelukast Sodium	Montelukast Sodium	Dr.Reddy's Laboratories Limited	ANDA	Current
68084-875	Montelukast Sodium	Montelukast Sodium	American Health Packaging	ANDA	Current
68084-875	Montelukast Sodium	Montelukast Sodium	American Health Packaging	ANDA	Current
68084-875	Montelukast Sodium	Montelukast Sodium	American Health Packaging	ANDA	Current
68084-875	Montelukast Sodium	Montelukast Sodium	American Health Packaging	ANDA	Current
68084-875	Montelukast Sodium	Montelukast Sodium	American Health Packaging	ANDA	Current
68645-466	Montelukast Sodium	Montelukast Sodium	Legacy Pharmaceutical Pac	ANDA	Current
70518-1085	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1085	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1784	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1784	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current