Application 021409

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SINGULAIR	MONTELUKAST SODIUM	GRANULE;ORAL	EQ 4MG BASE/PACKET	Yes	Yes

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
N021409-001	SINGULAIR	MONTELUKAST SODIUM	EQ 4MG BASE/PACKET	GRANULE / ORAL		RLD	2002-07-26

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL		RLD	2002-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021409-001	SINGULAIR	EQ 4MG BASE/PACKET	GRANULE / ORAL	AB	RLD, RS	2002-07-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021409-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021409-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021409-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021409-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021409-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021409-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021409-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021409-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021409-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021409-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021409-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021409-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021409-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021409-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021409-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021409-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021409-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021409-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021409-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021409-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021409-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021409-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021409-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021409-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021409-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021409-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021409-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021409-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021409-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021409-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021409-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021409-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021409-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021409-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021409-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021409-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021409-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021409-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021409-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021409-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021409-001	8007830	2022-10-24	Drug product	2011-09-29	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SINGULAIR	MONTELUKAST SODIUM	Organon LLC	482dcc92-b47f-4ea6-854a-f5ac2aea7842	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021409 application number: NDA021409 ndc (product): 78206-171

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-3841	SINGULAIR	montelukast sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-3841	SINGULAIR	montelukast sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-3841	SINGULAIR	montelukast sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-3841	SINGULAIR	montelukast sodium	Merck Sharp & Dohme Corp.	NDA	Current
66993-416	Montelukast Sodium	montelukast sodium	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-416	Montelukast Sodium	montelukast sodium	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
78206-171	SINGULAIR	montelukast sodium	Organon LLC	NDA	Current
78206-171	SINGULAIR	montelukast sodium	Organon LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66352	SUPPL	2021-02-24
66351	SUPPL	2021-02-24
66336	SUPPL	2021-02-23
62759	SUPPL	2020-04-30
62758	SUPPL	2020-04-30
62753	SUPPL	2020-04-30
59676	SUPPL	2019-08-12
59673	SUPPL	2019-08-12
57082	SUPPL	2018-12-31
57081	SUPPL	2018-12-31
57027	SUPPL	2018-12-26
57026	SUPPL	2018-12-26
46172	SUPPL	2016-12-15
46163	SUPPL	2016-12-15
15388	SUPPL	2014-12-19
5276	SUPPL	2014-11-28
15387	SUPPL	2013-12-31
5275	SUPPL	2013-12-31
36840	SUPPL	2013-03-26
27692	SUPPL	2013-03-22
36839	SUPPL	2012-10-22
27691	SUPPL	2012-10-22
5274	SUPPL	2012-10-02
15386	SUPPL	2012-09-28
5272	SUPPL	2012-03-28
15384	SUPPL	2012-03-26
5273	SUPPL	2011-12-21
15385	SUPPL	2011-12-20
27690	SUPPL	2011-05-03
36838	SUPPL	2011-04-29
15383	SUPPL	2010-08-19
5271	SUPPL	2010-08-16
5270	SUPPL	2010-04-29
36837	SUPPL	2010-04-28
27689	SUPPL	2009-11-10
36836	SUPPL	2009-08-28
36835	SUPPL	2009-02-04
27688	SUPPL	2009-01-30
23654	ORIG	2008-08-12
36833	SUPPL	2008-06-05
36834	SUPPL	2008-04-29
5269	SUPPL	2008-04-28
5268	SUPPL	2008-04-22
15382	SUPPL	2008-03-13
5267	SUPPL	2008-03-11
21640	SUPPL	2007-07-09
21641	SUPPL	2007-07-06
36830	SUPPL	2007-04-20
27684	SUPPL	2007-04-20
27687	SUPPL	2006-12-28
15381	SUPPL	2006-12-14
36832	SUPPL	2006-05-22
27686	SUPPL	2006-05-22
27682	SUPPL	2005-12-06
36828	SUPPL	2005-12-05
36827	SUPPL	2005-07-29
5266	SUPPL	2005-07-29
36831	SUPPL	2005-06-29
27685	SUPPL	2005-06-29
36829	SUPPL	2005-05-27
27683	SUPPL	2005-05-27
21639	ORIG	2004-11-22
36826	SUPPL	2004-11-17
27681	SUPPL	2004-11-17
36825	SUPPL	2004-06-17
15380	SUPPL	2003-12-29
5265	SUPPL	2003-12-23
5264	SUPPL	2003-10-09
15379	SUPPL	2003-04-09
5263	SUPPL	2003-01-23
15378	ORIG	2002-07-26
5262	ORIG	2002-07-26