Application 091576

Type: ANDA
Sponsor: VINTAGE PHARMS LLC

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
A091576-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL			2012-08-03

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091576-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	2012-08-03	`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 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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-4655	Montelukast Sodium	Montelukast Sodium	Par Pharmaceutical	ANDA	Current
0603-4655	Montelukast Sodium	Montelukast Sodium	Par Pharmaceutical	ANDA	Current
0904-6529	Montelukast Sodium	Montelukast Sodium	Major Pharmaceuticals	ANDA	Current
53808-0690	Montelukast Sodium	Montelukast Sodium	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0995	Montelukast Sodium	Montelukast Sodium	State of Florida DOH Central Pharmacy	ANDA	Current
55154-7638	Montelukast Sodium	Montelukast Sodium	Cardinal Health	ANDA	Current
55154-7638	Montelukast Sodium	Montelukast Sodium	Cardinal Health	ANDA	Current
64205-655	Montelukast Sodium	Montelukast Sodium	ReadyMeds	ANDA	Current
68151-3494	Montelukast Sodium	Montelukast Sodium	Carilion Materials Management	ANDA	Current
68151-3498	Montelukast Sodium	Montelukast Sodium	Carilion Materials Management	ANDA	Current
70518-0805	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0805	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
71610-051	Montelukast Sodium	Montelukast Sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31538	ORIG	2012-08-06