Application 203328

Type: ANDA
Sponsor: AJANTA PHARMA LTD

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 44.

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
A203328-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL			2015-07-31
A203328-002	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL			2015-07-31

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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A203328-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203328-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203328-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203328-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203328-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203328-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203328-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203328-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203328-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203328-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203328-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203328-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203328-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203328-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203328-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203328-002	AB	1	`ea99ee380514…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Ajanta Pharma USA Inc.	67070e4e-f755-46b3-b900-fcc1993a0546	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203328 application number: ANDA203328 ndc (product): 27241-016 ndc (product): 27241-017
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Proficient Rx LP	54014b67-3163-4c8f-b93a-229cd231ca6b	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203328 application number: ANDA203328 ndc (product): 63187-751
MONTELUKAST SODIUM	MONTELUKAST	Proficient Rx LP	cab84c43-96a3-4868-88da-3126685edf00	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203328 application number: ANDA203328 ndc (product): 71205-128

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 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-016	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Ajanta Pharma Limited	ANDA	Current
27241-016	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Ajanta Pharma USA Inc.	ANDA	Current
27241-016	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Ajanta Pharma Limited	ANDA	Current
27241-016	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Ajanta Pharma Limited	ANDA	Current
27241-016	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Ajanta Pharma Limited	ANDA	Current
27241-016	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Ajanta Pharma Limited	ANDA	Current
27241-017	MONTELUKAST SODIUM	MONTELUKAST	Ajanta Pharma Limited	ANDA	Current
27241-017	MONTELUKAST SODIUM	MONTELUKAST	Ajanta Pharma USA Inc.	ANDA	Current
27241-017	MONTELUKAST SODIUM	MONTELUKAST	Ajanta Pharma Limited	ANDA	Current
27241-017	MONTELUKAST SODIUM	MONTELUKAST	Ajanta Pharma Limited	ANDA	Current
27241-017	MONTELUKAST SODIUM	MONTELUKAST	Ajanta Pharma Limited	ANDA	Current
27241-017	MONTELUKAST SODIUM	MONTELUKAST	Ajanta Pharma Limited	ANDA	Current
53217-357	MONTELUKAST SODIUM	MONTELUKAST	Aidarex Pharmaceuticals LLC	ANDA	Current
63187-751	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Proficient Rx LP	ANDA	Current
63187-751	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Proficient Rx LP	ANDA	Current
63629-8235	MONTELUKAST SODIUM	MONTELUKAST	Bryant Ranch Prepack	ANDA	Current
63629-8235	MONTELUKAST SODIUM	MONTELUKAST	Bryant Ranch Prepack	ANDA	Current
68788-7668	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7668	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7668	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-128	MONTELUKAST SODIUM	MONTELUKAST	Proficient Rx LP	ANDA	Current
71205-128	MONTELUKAST SODIUM	MONTELUKAST	Proficient Rx LP	ANDA	Current
71335-0033	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0033	MONTELUKAST SODIUM	MONTELUKAST SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0629	MONTELUKAST SODIUM	MONTELUKAST	Bryant Ranch Prepack	ANDA	Current
71335-0629	MONTELUKAST SODIUM	MONTELUKAST	Bryant Ranch Prepack	ANDA	Current