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 1.

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 · 82 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	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…`
2022-03-09 01:35 UTC	2022-03	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209011-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209011-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2017-04-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	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…`
2022-03-09 01:35 UTC	2022-03	A209011-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209011-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209011-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209011-002	AB	1	`782e0a99824c…`

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 3 · 53 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Montelukast Sodium	MONTELUKAST SODIUM	Torrent Pharmaceuticals Limited	da038cf6-cfad-43a4-ab8e-d81d028d6087	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
montelukast sodium	MONTELUKAST SODIUM	Preferred Pharmaceuticals Inc.	1eeb3123-9e93-4681-8096-800a7c7acf8a	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: montelukast sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Preferred Pharmaceuticals Inc.	64a3b181-e8d8-4caf-9f1b-e0063d0bd94a	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Rising Pharma Holdings, Inc.	49669ac0-0bb5-4576-bed5-9e85e0d76a44	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	PD-Rx Pharmaceuticals, Inc.	c69ab399-8ea6-4002-9271-b6a57c862b14	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	7ff11e37-9ea5-40b6-96f7-4caf27cab756	2026-03-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: montelukast sodium generic name: MONTELUKAST SODIUM
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	1a312a28-8472-4cab-a7dd-d01cd8b2765a	2026-03-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: montelukast sodium generic name: MONTELUKAST SODIUM
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	25b2049d-3a93-4ac3-8de6-14f5d7ce0315	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: montelukast sodium generic name: MONTELUKAST SODIUM
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	04b3faff-1ea1-4d2a-aa31-9d6e742e1759	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: montelukast sodium generic name: MONTELUKAST SODIUM
montelukast sodium	MONTELUKAST SODIUM	Preferred Pharmaceuticals, Inc.	09b0bc9e-3035-45b4-b61b-4aca70848360	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: montelukast sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Redpharm Drug	2fbdf1be-a37f-879b-e063-6394a90aa20d	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Chartwell RX, LLC	5cb4298c-10b1-4d6f-95ad-4aad72daf249	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MONTELUKAST SODIUM generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	AvKARE	ed2caffa-a75c-1c27-ae30-2d8280eaea7d	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
MONTELUKAST	MONTELUKAST SODIUM	A-S Medication Solutions	da9821f1-536a-416b-9594-210bde0cefaf	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	AvPAK	2f90a573-27fd-cc16-f3d1-8c4d630224a0	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	PD-Rx Pharmaceuticals, Inc.	c9ec1996-6a54-4622-b8a6-57dea49f6b35	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	PD-Rx Pharmaceuticals, Inc.	6ffff72c-8784-477b-8722-5434a19881a0	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST	Amneal Pharmaceuticals LLC	ccbbf0d6-efd9-4fdd-9e7b-e3d293062609	2025-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Ajanta Pharma USA Inc.	67070e4e-f755-46b3-b900-fcc1993a0546	2025-08-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MONTELUKAST SODIUM generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Cardinal Health 107, LLC	9287d2f1-2414-4ee2-aecc-b6b59c6a0a4c	2025-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM

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