Application 202843

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;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
A202843-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB		2014-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202843-001	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 2 · 41 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	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A202843-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202843-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202843-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202843-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202843-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202843-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202843-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202843-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202843-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202843-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202843-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202843-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202843-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202843-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202843-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202843-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202843-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202843-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202843-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202843-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202843-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202843-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202843-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202843-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202843-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202843-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202843-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202843-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202843-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202843-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202843-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202843-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202843-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202843-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202843-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202843-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202843-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202843-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202843-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202843-001	AB	1	`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 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Montelukast	MONTELUKAST	Preferred Pharmaceuticals, Inc.	94642db1-5c75-44c4-92b4-8385b486df82	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843 ndc (product): 68788-8099
Montelukast	MONTELUKAST	REMEDYREPACK INC.	ecaa9b4b-5941-4af5-930c-35e9f3b2b4ba	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843 ndc (product): 70518-3133
Montelukast	MONTELUKAST	AvPAK	d7870c45-5a8b-8369-e053-2a95a90ae1f3	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843 ndc (product): 50268-556
MONTELUKAST	MONTELUKAST SODIUM	A-S Medication Solutions	da9821f1-536a-416b-9594-210bde0cefaf	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843
Montelukast Sodium	MONTELUKAST SODIUM	Cardinal Health 107, LLC	9287d2f1-2414-4ee2-aecc-b6b59c6a0a4c	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843 ndc (product): 55154-8075
Montelukast Sodium	MONTELUKAST SODIUM	Major Pharmaceuticals	a4dc63cf-8145-42f4-9437-93b414d2aed4	2025-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843 ndc (product): 0904-6808
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Camber Pharmaceuticals, Inc.	97a682c2-7e00-4d07-a5ac-4436c977f842	2025-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843 ndc (product): 31722-726
Montelukast	MONTELUKAST	Quallent Pharmaceuticals Health LLC	5d71088b-b0fa-4bf0-a6e7-6163bd9e0dd4	2025-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843 ndc (product): 82009-009
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Direct_Rx	f3bdf2a3-d661-5128-e053-2995a90a4661	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843
Montelukast	MONTELUKAST	Bryant Ranch Prepack	6b26218d-52a6-4109-90e4-412a17d14fcf	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843 ndc (product): 71335-1979
Montelukast	MONTELUKAST	A-S Medication Solutions	6741830f-5d90-4066-bc3b-065059bc150d	2023-11-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843 ndc (product): 50090-6108
Montelukast	MONTELUKAST	XLCare Pharmaceuticals Inc.	82d65eea-c7c9-4e16-9176-46c43f00f0f6	2023-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843 ndc (product): 72865-175
Montelukast	MONTELUKAST	Aphena Pharma Solutions - Tennessee, LLC	4fe3c0d4-94ff-43ca-9d24-54676fe593fe	2021-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843 ndc (product): 71610-563

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6808	Montelukast	Montelukast	Major Pharmaceuticals	ANDA	Current
0904-6808	Montelukast	Montelukast	Major Pharmaceuticals	ANDA	Current
0904-6808	Montelukast	Montelukast	Major Pharmaceuticals	ANDA	Current
31722-726	Montelukast	Montelukast	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-726	Montelukast	Montelukast	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-726	Montelukast	Montelukast	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-6108	Montelukast	Montelukast	A-S Medication Solutions	ANDA	Current
50268-556	Montelukast	Montelukast	AvPAK	ANDA	Current
50268-556	Montelukast	Montelukast	AvPAK	ANDA	Current
55154-8075	Montelukast	Montelukast	Cardinal Health	ANDA	Current
55154-8075	Montelukast	Montelukast	Cardinal Health 107, LLC	ANDA	Current
55154-8075	Montelukast	Montelukast	Cardinal Health	ANDA	Current
68071-1561	Montelukast	Montelukast	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2425	Montelukast	Montelukast	NuCare Pharmaceuticals,Inc.	ANDA	Current
68645-560	Montelukast	Montelukast	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-560	Montelukast	Montelukast	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-560	Montelukast	Montelukast	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-560	Montelukast	Montelukast	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68788-8099	Montelukast	Montelukast	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8099	Montelukast	Montelukast	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-3133	Montelukast	Montelukast	REMEDYREPACK INC.	ANDA	Current
70518-3133	Montelukast	Montelukast	REMEDYREPACK INC.	ANDA	Current
70518-3133	Montelukast	Montelukast	REMEDYREPACK INC.	ANDA	Current
71335-1979	Montelukast	Montelukast	Bryant Ranch Prepack	ANDA	Current
71335-1979	Montelukast	Montelukast	Bryant Ranch Prepack	ANDA	Current
71610-563	Montelukast	Montelukast	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72865-175	Montelukast	Montelukast	XLCare Pharmaceuticals Inc.	ANDA	Current
82009-009	Montelukast	Montelukast	Quallent Pharmaceuticals Health LLC	ANDA	Current