Application 079142

Type: ANDA
Sponsor: MYLAN PHARMS INC

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
A079142-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL			2012-08-03
A079142-002	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / 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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079142-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079142-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	2012-08-03	`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 3 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	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

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5204	Montelukast Sodium	montelukast sodium	Mylan Pharmaceuticals Inc	ANDA	Current
0378-5205	Montelukast Sodium	montelukast sodium	Mylan Pharmaceuticals Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31416	ORIG	2012-08-06