Application 209011

Type: ANDA
Sponsor: CSPC OUYI

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 43.

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
A209011-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB		2017-04-18
A209011-002	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB		2017-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A209011-001	AB
A209011-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209011-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209011-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209011-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209011-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209011-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209011-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209011-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209011-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209011-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209011-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209011-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209011-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209011-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209011-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209011-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209011-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209011-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209011-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209011-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209011-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209011-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209011-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209011-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209011-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209011-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209011-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209011-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209011-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209011-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209011-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209011-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209011-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209011-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209011-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209011-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209011-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209011-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209011-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209011-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209011-002	AB	1	`74a2ff9319b5…`

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 2 of 3 · 50 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Camber Pharmaceuticals, Inc.	97a682c2-7e00-4d07-a5ac-4436c977f842	2025-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MONTELUKAST SODIUM generic name: MONTELUKAST SODIUM
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Direct_Rx	f3bdf2a3-d661-5128-e053-2995a90a4661	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MONTELUKAST SODIUM generic name: MONTELUKAST SODIUM
MONTELUKAST SODIUM	MONTELUKAST SODIUM	DIRECT RX	c2d834e6-7b38-d266-e053-2995a90a27ef	2025-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MONTELUKAST SODIUM generic name: MONTELUKAST SODIUM
montelukast sodium	MONTELUKAST SODIUM	NuCare Pharmaceuticals,Inc.	a7c11cbe-0834-27a5-e053-2995a90ac43f	2024-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: montelukast sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	American Health Packaging	fb1b2e4e-a840-447b-b943-ad0b6acc32b5	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
montelukast sodium	MONTELUKAST SODIUM	Bryant Ranch Prepack	3ff4100f-11e3-4d6a-ab88-83bd605a1818	2024-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: montelukast sodium generic name: MONTELUKAST SODIUM
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Rising Pharma Holdings, Inc.	75723c5a-3c9e-468a-bc65-57b4c755889a	2024-07-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MONTELUKAST SODIUM generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	NuCare Pharmaceuticals,Inc.	566a8fd7-fc00-2297-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	NuCare Pharmaceuticals,Inc.	549f1d1a-81f5-29f5-e054-00144ff8d46c	2024-07-10	Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
montelukast sodium	MONTELUKAST SODIUM	Bryant Ranch Prepack	9beb1510-f3af-4269-a9d0-e2bd41ac369b	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: montelukast sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Aurobindo Pharma Limited	ba42b0a9-83f1-4283-a853-f99cdd0761b9	2024-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Westminster Pharmaceuticals, LLC	c0daaaf3-6717-4a01-e053-2995a90af2d8	2024-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Bryant Ranch Prepack	4ba27278-6249-4546-9331-b19302cbf2db	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	07d5fbea-b183-41c9-a20f-30da1f44ab1b	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Lannett Company, Inc.	c43d1edb-c162-4317-9a89-d84e4eff5512	2023-07-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast sodium	MONTELUKAST SODIUM	Macleods Pharmaceuticals Limited	ce512844-5220-4661-809f-56d088699c9c	2023-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast sodium generic name: MONTELUKAST SODIUM
montelukast sodium	MONTELUKAST SODIUM	Unichem Pharmaceuticals (USA), Inc.	9e375c07-70db-458c-9336-22a7037b0a5f	2023-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: montelukast sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Aurobindo Pharma Limited	9a3bfc59-0ca6-4433-abf5-41659bfe0a8f	2023-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	461f2aaa-e091-478e-97c1-27a089db8cdc	2023-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Dr.Reddy's Laboratories Limited	3d4451a9-d73d-b9de-68ec-853bfeff6e4b	2022-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58657-715	Montelukast Sodium	Montelukast Sodium	Method Pharmaceuticals, LLC	ANDA	Current
58657-715	Montelukast Sodium	Montelukast Sodium	Method Pharmaceuticals, LLC	ANDA	Current
58657-716	Montelukast Sodium	Montelukast Sodium	Method Pharmaceuticals, LLC	ANDA	Current
58657-716	Montelukast Sodium	Montelukast Sodium	Method Pharmaceuticals, LLC	ANDA	Current
69844-039	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-040	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-074	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-075	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Graviti Pharmaceuticals Private Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48075	ORIG	2017-04-21