Application 090926

Type: ANDA
Sponsor: GLENMARK GENERICS

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
A090926-001	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
A090926-001	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	A090926-001	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	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090926-001	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	A090926-001	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	A090926-001	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	A090926-001	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	A090926-001	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	A090926-001	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	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090926-001	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	A090926-001	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	A090926-001	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	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090926-001	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	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090926-001	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	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090926-001	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	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090926-001	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	A090926-001	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	A090926-001	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	A090926-001	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	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090926-001	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	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090926-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`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	A090926-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090926-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090926-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090926-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090926-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090926-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090926-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090926-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090926-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090926-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090926-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090926-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090926-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090926-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090926-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090926-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090926-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090926-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090926-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090926-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090926-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090926-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090926-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090926-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090926-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090926-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090926-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090926-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090926-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090926-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090926-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090926-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090926-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090926-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090926-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090926-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090926-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090926-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090926-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090926-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33261-969	montelukast sodium	montelukast sodium	Aidarex Pharmaceuticals LLC	ANDA	Current
68001-248	montelukast sodium	montelukast sodium	BluePoint Laboratories	ANDA	Current
68001-248	montelukast sodium	montelukast sodium	BluePoint Laboratories	ANDA	Current
68462-392	montelukast sodium	montelukast sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9306	ORIG	2012-08-06