Application 200405

Type: ANDA
Sponsor: LANNETT CO 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 42.

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
A200405-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB		2012-08-03
A200405-002	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB		2012-08-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A200405-001	AB
A200405-002	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 · 84 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	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A200405-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200405-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200405-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200405-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200405-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200405-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200405-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200405-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200405-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200405-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200405-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200405-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200405-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200405-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200405-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200405-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200405-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200405-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200405-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200405-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200405-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200405-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200405-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200405-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200405-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200405-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200405-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200405-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200405-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200405-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200405-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200405-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200405-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200405-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200405-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200405-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200405-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200405-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200405-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200405-002	AB	1	`bb7c543d1eb4…`

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Chartwell RX, LLC	5cb4298c-10b1-4d6f-95ad-4aad72daf249	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200405 application number: ANDA200405
Montelukast Sodium	MONTELUKAST SODIUM	AvKARE	ed2caffa-a75c-1c27-ae30-2d8280eaea7d	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200405 application number: ANDA200405 ndc (product): 42291-623 ndc (product): 42291-622
Montelukast Sodium	MONTELUKAST SODIUM	AvPAK	2f90a573-27fd-cc16-f3d1-8c4d630224a0	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200405 application number: ANDA200405 ndc (product): 50268-573 ndc (product): 50268-574
Montelukast Sodium	MONTELUKAST SODIUM	Lannett Company, Inc.	c43d1edb-c162-4317-9a89-d84e4eff5512	2023-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200405 application number: ANDA200405 ndc (product): 62175-205 ndc (product): 62175-204
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	83c35a3d-0bbc-4598-bf76-ab0c2903bf19	2021-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200405 application number: ANDA200405 ndc (product): 71205-189
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	0f2dbf17-bce0-4e09-8c22-898d93be80da	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200405 application number: ANDA200405 ndc (product): 63187-896

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-622	Montelukast Sodium	Montelukast Sodium	AvKARE, Inc.	ANDA	Current
42291-622	Montelukast Sodium	Montelukast Sodium	AvKARE, Inc.	ANDA	Current
42291-622	Montelukast Sodium	Montelukast Sodium	AvKARE	ANDA	Current
42291-622	Montelukast Sodium	Montelukast Sodium	AvKARE	ANDA	Current
42291-622	Montelukast Sodium	Montelukast Sodium	AvKARE	ANDA	Current
42291-623	Montelukast Sodium	Montelukast Sodium	AvKARE, Inc.	ANDA	Current
42291-623	Montelukast Sodium	Montelukast Sodium	AvKARE, Inc.	ANDA	Current
42291-623	Montelukast Sodium	Montelukast Sodium	AvKARE	ANDA	Current
42291-623	Montelukast Sodium	Montelukast Sodium	AvKARE	ANDA	Current
42291-623	Montelukast Sodium	Montelukast Sodium	AvKARE	ANDA	Current
50268-573	Montelukast Sodium	Montelukast Sodium	AvPAK	ANDA	Current
50268-573	Montelukast Sodium	Montelukast Sodium	AvPAK	ANDA	Current
50268-573	Montelukast Sodium	Montelukast Sodium	AvPAK	ANDA	Current
50268-573	Montelukast Sodium	Montelukast Sodium	AvPAK	ANDA	Current
50268-574	Montelukast Sodium	Montelukast Sodium	AvPAK	ANDA	Current
50268-574	Montelukast Sodium	Montelukast Sodium	AvPAK	ANDA	Current
50268-574	Montelukast Sodium	Montelukast Sodium	AvPAK	ANDA	Current
50268-574	Montelukast Sodium	Montelukast Sodium	AvPAK	ANDA	Current
62175-204	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc.	ANDA	Current
62175-204	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc.	ANDA	Current
62175-204	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc.	ANDA	Current
62175-204	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc.	ANDA	Current
62175-204	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc.	ANDA	Current
62175-204	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc..	ANDA	Current
62175-204	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc.	ANDA	Current
62175-204	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc.	ANDA	Current
62175-205	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc.	ANDA	Current
62175-205	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc.	ANDA	Current
62175-205	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc.	ANDA	Current
62175-205	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc.	ANDA	Current
62175-205	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc.	ANDA	Current
62175-205	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc..	ANDA	Current
62175-205	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc.	ANDA	Current
62175-205	Montelukast Sodium	Montelukast Sodium	Lannett Company, Inc.	ANDA	Current
63187-896	Montelukast Sodium	Montelukast Sodium	Proficient Rx LP	ANDA	Current
63187-896	Montelukast Sodium	Montelukast Sodium	Proficient Rx LP	ANDA	Current
70934-485	Montelukast Sodium	Montelukast Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-189	Montelukast Sodium	Montelukast Sodium	Proficient Rx LP	ANDA	Current
71205-189	Montelukast Sodium	Montelukast Sodium	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9823	ORIG	2012-08-06