Application 204093

Type: ANDA
Sponsor: HETERO LABS LTD V

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 1.

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
A204093-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB		2015-05-22
A204093-002	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB		2015-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204093-001	AB
A204093-002	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 · 82 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	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A204093-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204093-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204093-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204093-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204093-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204093-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204093-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204093-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204093-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204093-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204093-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204093-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204093-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204093-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204093-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204093-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204093-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204093-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204093-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204093-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204093-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204093-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204093-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204093-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204093-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204093-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204093-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204093-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204093-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204093-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204093-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204093-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204093-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204093-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204093-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204093-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204093-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204093-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204093-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204093-002	AB	1	`782e0a99824c…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	7ff11e37-9ea5-40b6-96f7-4caf27cab756	2026-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093 ndc (product): 50090-4705
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	1a312a28-8472-4cab-a7dd-d01cd8b2765a	2026-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	25b2049d-3a93-4ac3-8de6-14f5d7ce0315	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093 ndc (product): 50090-2921
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	04b3faff-1ea1-4d2a-aa31-9d6e742e1759	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093
montelukast sodium	MONTELUKAST SODIUM	Preferred Pharmaceuticals, Inc.	09b0bc9e-3035-45b4-b61b-4aca70848360	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093 ndc (product): 68788-7669
MONTELUKAST SODIUM	MONTELUKAST SODIUM	DIRECT RX	c2d834e6-7b38-d266-e053-2995a90a27ef	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093 ndc (product): 72189-223
montelukast sodium	MONTELUKAST SODIUM	Bryant Ranch Prepack	3ff4100f-11e3-4d6a-ab88-83bd605a1818	2024-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093 ndc (product): 71335-1602
montelukast sodium	MONTELUKAST SODIUM	Camber Pharmaceuticals, Inc.	23964723-2df8-4d0a-a53d-8538469672f1	2021-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093 ndc (product): 31722-727 ndc (product): 31722-728

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-727	montelukast sodium	montelukast sodium	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-727	montelukast sodium	montelukast sodium	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-727	montelukast sodium	montelukast sodium	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-727	montelukast sodium	montelukast sodium	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-728	montelukast sodium	montelukast sodium	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-728	montelukast sodium	montelukast sodium	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-728	montelukast sodium	montelukast sodium	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-728	montelukast sodium	montelukast sodium	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-2921	montelukast sodium	montelukast sodium	A-S Medication Solutions	ANDA	Current
50090-2921	montelukast sodium	montelukast sodium	A-S Medication Solutions	ANDA	Current
50090-4705	montelukast sodium	montelukast sodium	A-S Medication Solutions	ANDA	Current
50090-4705	montelukast sodium	montelukast sodium	A-S Medication Solutions	ANDA	Current
68071-2486	montelukast sodium	montelukast sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7669	montelukast sodium	montelukast sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7669	montelukast sodium	montelukast sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7669	montelukast sodium	montelukast sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7771	montelukast sodium	montelukast sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7771	montelukast sodium	montelukast sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7771	montelukast sodium	montelukast sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2881	montelukast sodium	montelukast sodium	REMEDYREPACK INC.	ANDA	Current
70518-2881	montelukast sodium	montelukast sodium	REMEDYREPACK INC.	ANDA	Current
71335-1602	montelukast sodium	montelukast sodium	Bryant Ranch Prepack	ANDA	Current
71335-1602	montelukast sodium	montelukast sodium	Bryant Ranch Prepack	ANDA	Current
71335-1602	montelukast sodium	montelukast sodium	Bryant Ranch Prepack	ANDA	Current
72189-223	MONTELUKAST SODIUM	MONTELUKAST SODIUM	DIRECT RX	ANDA	Current