FDA.reportPublic FDA data

Application 020829

Type
NDA
Sponsor
MSD MERCK CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002SINGULAIRMONTELUKAST SODIUMTABLET;ORALEQ 10MG BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020829-002SINGULAIRMONTELUKAST SODIUMEQ 10MG BASETABLET / ORALABRLD, RS1998-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020829-002AB

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020829-002SINGULAIREQ 10MG BASETABLET / ORALABRLD, RS1998-02-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020829-002SINGULAIREQ 10MG BASETABLET / ORALABRLD, RS1998-02-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020829-002SINGULAIREQ 10MG BASETABLET / ORALABRLD, RS1998-02-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020829-002SINGULAIREQ 10MG BASETABLET / ORALABRLD, RS1998-02-20a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N020829-002AB1c2088c7a36db…
2026-09-14 22:38:342026-08N020829-002AB184e616aacf4f…
2026-08-18 06:07:402026-07N020829-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020829-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020829-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020829-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020829-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020829-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020829-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020829-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020829-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020829-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020829-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020829-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020829-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020829-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020829-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020829-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020829-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020829-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020829-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020829-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020829-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020829-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020829-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020829-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020829-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020829-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020829-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020829-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020829-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020829-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020829-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020829-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020829-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020829-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020829-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020829-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020829-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020829-002AB13a93d1ddd44b…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SINGULAIRMONTELUKAST SODIUMOrganon LLC482dcc92-b47f-4ea6-854a-f5ac2aea78422025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020829
application number: NDA020829
ndc (product): 78206-172

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-9117SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-9117SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-9117SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-9117SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
21695-221SINGULAIRmontelukast sodiumRebel Distributors CorpNDACurrent
68258-3033SINGULAIRmontelukast sodiumDispensing Solutions Inc.NDACurrent
78206-172SINGULAIRmontelukast sodiumOrganon LLCNDACurrent
78206-172SINGULAIRmontelukast sodiumOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68745SUPPL2021-09-24
66348SUPPL2021-02-24
66347SUPPL2021-02-24
66334SUPPL2021-02-23
62755SUPPL2020-04-30
62754SUPPL2020-04-30
62751SUPPL2020-04-30
59674SUPPL2019-08-12
59671SUPPL2019-08-12
57078SUPPL2018-12-31
57069SUPPL2018-12-30
57023SUPPL2018-12-26
57022SUPPL2018-12-26
46161SUPPL2016-12-15
46176SUPPL2016-12-14
35443SUPPL2014-12-19
25958SUPPL2014-11-28
25957SUPPL2013-12-31
13523SUPPL2013-12-31
13522SUPPL2013-03-26
25956SUPPL2013-03-22
13519SUPPL2012-10-22
3456SUPPL2012-10-22
25955SUPPL2012-10-02
13521SUPPL2012-09-28
13520SUPPL2012-07-18
25954SUPPL2012-07-17
25953SUPPL2012-03-28
35442SUPPL2012-03-26
41732SUPPL2012-02-14
3455SUPPL2011-12-21
13518SUPPL2011-12-20
25952SUPPL2011-06-17
3454SUPPL2011-05-03
13517SUPPL2011-04-29
35441SUPPL2010-08-19
3453SUPPL2010-08-16
25951SUPPL2010-04-29
13516SUPPL2010-04-28
3452SUPPL2009-11-10
13515SUPPL2009-09-15
13514SUPPL2009-02-04
25950SUPPL2009-01-30
23601ORIG2008-08-12
13512SUPPL2008-06-05
13513SUPPL2008-04-29
25949SUPPL2008-04-28
3451SUPPL2008-04-22
13511SUPPL2008-03-11
3450SUPPL2008-03-11
41730SUPPL2007-07-09
41731SUPPL2007-07-06
20987SUPPL2007-07-06
35438SUPPL2007-04-20
25948SUPPL2007-04-20
25947SUPPL2007-04-20
3449SUPPL2007-04-20
3445SUPPL2007-04-20
3448SUPPL2006-12-28
13510SUPPL2006-12-14
35440SUPPL2006-05-22
3447SUPPL2006-05-22
25945SUPPL2005-12-06
13508SUPPL2005-12-05
13507SUPPL2005-07-29
3444SUPPL2005-07-29
35439SUPPL2005-06-29
3446SUPPL2005-06-29
25946SUPPL2005-05-27
13509SUPPL2005-05-27
35437SUPPL2005-01-11
3443SUPPL2005-01-11
35436SUPPL2004-11-17
25944SUPPL2004-11-17
35435SUPPL2003-12-29
25943SUPPL2003-12-23
35434SUPPL2003-11-13
25942SUPPL2003-11-13
35433SUPPL2003-10-10
25941SUPPL2003-10-09
13505SUPPL2003-04-24
13506SUPPL2003-04-07
25940SUPPL2002-12-31
41729SUPPL2001-07-05
41728ORIG1998-02-20
35432ORIG1998-02-20
25939ORIG1998-02-20
53346ORIG1900-01-01
53345ORIG1900-01-01
53344ORIG1900-01-01