Application 204290

Type: ANDA
Sponsor: UNICHEM LABS LTD

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
A204290-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB		2015-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204290-001	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 · 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	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204290-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2015-10-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A204290-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204290-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204290-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204290-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204290-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204290-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204290-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204290-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204290-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204290-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204290-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204290-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204290-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204290-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204290-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204290-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204290-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204290-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204290-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204290-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204290-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204290-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204290-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204290-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204290-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204290-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204290-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204290-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204290-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204290-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204290-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204290-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204290-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204290-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204290-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204290-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204290-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204290-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204290-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204290-001	AB	1	`e64feba35796…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
montelukast sodium	MONTELUKAST SODIUM	Preferred Pharmaceuticals Inc.	1eeb3123-9e93-4681-8096-800a7c7acf8a	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204290 application number: ANDA204290
montelukast sodium	MONTELUKAST SODIUM	NuCare Pharmaceuticals,Inc.	a7c11cbe-0834-27a5-e053-2995a90ac43f	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204290 application number: ANDA204290 ndc (product): 68071-5278
montelukast sodium	MONTELUKAST SODIUM	Bryant Ranch Prepack	9beb1510-f3af-4269-a9d0-e2bd41ac369b	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204290 application number: ANDA204290 ndc (product): 71335-1995
montelukast sodium	MONTELUKAST SODIUM	Unichem Pharmaceuticals (USA), Inc.	9e375c07-70db-458c-9336-22a7037b0a5f	2023-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204290 application number: ANDA204290 ndc (product): 29300-220
montelukast sodium	MONTELUKAST SODIUM	Proficient Rx LP	2ce48faf-4504-488a-8b20-3e8d4f008fb2	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204290 application number: ANDA204290 ndc (product): 71205-181

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-220	montelukast sodium	montelukast sodium	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-220	montelukast sodium	montelukast sodium	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-220	montelukast sodium	montelukast sodium	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-220	montelukast sodium	montelukast sodium	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-220	montelukast sodium	montelukast sodium	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-220	montelukast sodium	montelukast sodium	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
50090-2480	montelukast sodium	montelukast sodium	A-S Medication Solutions	ANDA	Current
50090-2480	montelukast sodium	montelukast sodium	A-S Medication Solutions	ANDA	Current
50090-2480	montelukast sodium	montelukast sodium	A-S Medication Solutions	ANDA	Current
50090-4919	montelukast sodium	montelukast sodium	A-S Medication Solutions	ANDA	Current
50090-4919	montelukast sodium	montelukast sodium	A-S Medication Solutions	ANDA	Current
50090-4919	montelukast sodium	montelukast sodium	A-S Medication Solutions	ANDA	Current
67046-468	montelukast sodium	montelukast sodium	Contract Pharmacy Services-PA	ANDA	Current
68071-2846	montelukast sodium	montelukast sodium	NuCare Pharmceuticals,Inc.	ANDA	Current
68071-5278	montelukast sodium	montelukast sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5278	montelukast sodium	montelukast sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5278	montelukast sodium	montelukast sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
71205-181	montelukast sodium	montelukast sodium	Proficient Rx LP	ANDA	Current
71205-181	montelukast sodium	montelukast sodium	Proficient Rx LP	ANDA	Current
71205-181	montelukast sodium	montelukast sodium	Proficient Rx LP	ANDA	Current
71205-181	montelukast sodium	montelukast sodium	Proficient Rx LP	ANDA	Current
71335-1995	montelukast sodium	montelukast sodium	Bryant Ranch Prepack	ANDA	Current