Application 090655

Type: ANDA
Sponsor: HIKMA

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
A090655-001	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 · 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	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090655-001	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	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090655-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090655-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090655-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090655-001	AB	1	`ea99ee380514…`

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 3 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	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
montelukast sodium	MONTELUKAST SODIUM	Proficient Rx LP	2ce48faf-4504-488a-8b20-3e8d4f008fb2	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: montelukast sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e5	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Accord Healthcare Inc.	6eea668f-a2fa-447f-b2d5-4c754d13d9fa	2022-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	83c35a3d-0bbc-4598-bf76-ab0c2903bf19	2021-07-01	Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
montelukast sodium	MONTELUKAST SODIUM	Camber Pharmaceuticals, Inc.	23964723-2df8-4d0a-a53d-8538469672f1	2021-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: montelukast sodium generic name: MONTELUKAST SODIUM
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Proficient Rx LP	901385e5-7384-4c28-a36a-7dd84c36f5fd	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: MONTELUKAST SODIUM generic name: MONTELUKAST SODIUM
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Proficient Rx LP	54014b67-3163-4c8f-b93a-229cd231ca6b	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: MONTELUKAST SODIUM generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	8a724790-e1fb-4935-bb28-ce99455be5ef	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	0f2dbf17-bce0-4e09-8c22-898d93be80da	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Montelukast Sodium generic name: MONTELUKAST SODIUM
MONTELUKAST SODIUM	MONTELUKAST	Proficient Rx LP	cab84c43-96a3-4868-88da-3126685edf00	2019-10-01	Warnings, Adverse reactions	Name fallback brand 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
0054-0259	Montelukast Sodium	Montelukast Sodium	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0259	Montelukast Sodium	Montelukast Sodium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0259	Montelukast Sodium	Montelukast Sodium	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0259	Montelukast Sodium	Montelukast Sodium	West-Ward Pharmaceuticals	ANDA	Current
0054-0259	Montelukast Sodium	Montelukast Sodium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0259	Montelukast Sodium	Montelukast Sodium	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0259	Montelukast Sodium	Montelukast Sodium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0615-7983	Montelukast Sodium	Montelukast Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31484	ORIG	2012-08-06