Application 021687

Type
NDA
Sponsor
MSD INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VYTORINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;10MGYesNo
002VYTORINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;20MGYesNo
003VYTORINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;40MGYesNo
004VYTORINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;80MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021687-001VYTORINEZETIMIBE; SIMVASTATIN10MG;10MGTABLET / ORALABRLD2004-07-23
N021687-002VYTORINEZETIMIBE; SIMVASTATIN10MG;20MGTABLET / ORALABRLD2004-07-23
N021687-003VYTORINEZETIMIBE; SIMVASTATIN10MG;40MGTABLET / ORALABRLD2004-07-23
N021687-004VYTORINEZETIMIBE; SIMVASTATIN10MG;80MGTABLET / ORALABRLD, RS2004-07-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N021687-001AB
N021687-002AB
N021687-003AB
N021687-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021687-001VYTORIN10MG;10MGTABLET / ORALABRLD2004-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021687-002VYTORIN10MG;20MGTABLET / ORALABRLD2004-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021687-003VYTORIN10MG;40MGTABLET / ORALABRLD2004-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021687-004VYTORIN10MG;80MGTABLET / ORALABRLD, RS2004-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021687-001VYTORIN10MG;10MGTABLET / ORALABRLD2004-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021687-002VYTORIN10MG;20MGTABLET / ORALABRLD2004-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021687-003VYTORIN10MG;40MGTABLET / ORALABRLD2004-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021687-004VYTORIN10MG;80MGTABLET / ORALABRLD, RS2004-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N021687-001VYTORIN10MG;10MGTABLET / ORALABRLD2004-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021687-002VYTORIN10MG;20MGTABLET / ORALABRLD2004-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021687-003VYTORIN10MG;40MGTABLET / ORALABRLD2004-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021687-004VYTORIN10MG;80MGTABLET / ORALABRLD, RS2004-07-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021687-001VYTORIN10MG;10MGTABLET / ORALABRLD2004-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021687-002VYTORIN10MG;20MGTABLET / ORALABRLD2004-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021687-003VYTORIN10MG;40MGTABLET / ORALABRLD2004-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021687-004VYTORIN10MG;80MGTABLET / ORALABRLD, RS2004-07-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021687-001VYTORIN10MG;10MGTABLET / ORALABRLD2004-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021687-002VYTORIN10MG;20MGTABLET / ORALABRLD2004-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021687-003VYTORIN10MG;40MGTABLET / ORALABRLD2004-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021687-004VYTORIN10MG;80MGTABLET / ORALABRLD, RS2004-07-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021687-001VYTORIN10MG;10MGTABLET / ORALABRLD2004-07-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021687-002VYTORIN10MG;20MGTABLET / ORALABRLD2004-07-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021687-003VYTORIN10MG;40MGTABLET / ORALABRLD2004-07-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021687-004VYTORIN10MG;80MGTABLET / ORALABRLD, RS2004-07-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021687-001VYTORIN10MG;10MGTABLET / ORALABRLD2004-07-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021687-002VYTORIN10MG;20MGTABLET / ORALABRLD2004-07-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021687-003VYTORIN10MG;40MGTABLET / ORALABRLD2004-07-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021687-004VYTORIN10MG;80MGTABLET / ORALABRLD, RS2004-07-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021687-001VYTORIN10MG;10MGTABLET / ORALABRLD2004-07-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021687-002VYTORIN10MG;20MGTABLET / ORALABRLD2004-07-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021687-003VYTORIN10MG;40MGTABLET / ORALABRLD2004-07-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021687-004VYTORIN10MG;80MGTABLET / ORALABRLD, RS2004-07-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021687-001VYTORIN10MG;10MGTABLET / ORALABRLD2004-07-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021687-002VYTORIN10MG;20MGTABLET / ORALABRLD2004-07-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021687-003VYTORIN10MG;40MGTABLET / ORALABRLD2004-07-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021687-004VYTORIN10MG;80MGTABLET / ORALABRLD, RS2004-07-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021687-001VYTORIN10MG;10MGTABLET / ORALABRLD2004-07-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N021687-002VYTORIN10MG;20MGTABLET / ORALABRLD2004-07-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N021687-003VYTORIN10MG;40MGTABLET / ORALABRLD2004-07-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N021687-004VYTORIN10MG;80MGTABLET / ORALABRLD, RS2004-07-23d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021687-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021687-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021687-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021687-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021687-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021687-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021687-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021687-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021687-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021687-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021687-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021687-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021687-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021687-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021687-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021687-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021687-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021687-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021687-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021687-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021687-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021687-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021687-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021687-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021687-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021687-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021687-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021687-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021687-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021687-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021687-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021687-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021687-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021687-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021687-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021687-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021687-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021687-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021687-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021687-004AB1d06236e962d9…

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
VYTORINEZETIMIBE AND SIMVASTATINOrganon LLC89b860d2-de83-468e-b7e8-76aeec2edca22026-01-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 021687
application number: NDA021687
ndc (product): 78206-176
ndc (product): 78206-175
ndc (product): 78206-177
ndc (product): 78206-174

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-325VYTORINezetimibe and simvastatinRebel Distributors CorpNDACurrent
21695-339VYTORINezetimibe and simvastatinRebel Distributors CorpNDACurrent
21695-827VYTORINezetimibe and simvastatinRebel Distributors CorpNDACurrent
55289-280VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-280VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-280VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-280VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-280VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-280VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-520VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-520VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-520VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-520VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-520VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-520VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
66582-311VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-311VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-311VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-311VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-311VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-311VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-312VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-312VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-312VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-312VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-312VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-312VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-313VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-313VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-313VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-313VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-313VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-313VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-315VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-315VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-315VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-315VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-315VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-315VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
78206-174VYTORINezetimibe and simvastatinOrganon LLCNDACurrent
78206-174VYTORINezetimibe and simvastatinOrganon LLCNDACurrent
78206-175VYTORINezetimibe and simvastatinOrganon LLCNDACurrent
78206-175VYTORINezetimibe and simvastatinOrganon LLCNDACurrent
78206-176VYTORINezetimibe and simvastatinOrganon LLCNDACurrent
78206-176VYTORINezetimibe and simvastatinOrganon LLCNDACurrent
78206-177VYTORINezetimibe and simvastatinOrganon LLCNDACurrent
78206-177VYTORINezetimibe and simvastatinOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78021SUPPL 2024-04-01
78010SUPPL 2024-04-01
77456SUPPL 2024-02-09
77455SUPPL 2024-02-09
77454SUPPL 2024-02-09
77453SUPPL 2024-02-09
77452SUPPL 2024-02-09
77451SUPPL 2024-02-09
77450SUPPL 2024-02-09
64730SUPPL2020-09-29
64703SUPPL2020-09-28
60571SUPPL2019-10-15
60439SUPPL2019-10-09
58208SUPPL2019-04-04
58193SUPPL2019-04-02
52777SUPPL2018-03-01
52776SUPPL2018-03-01
48430SUPPL2017-05-17
28372SUPPL2015-02-03
15982SUPPL2015-02-03
5979SUPPL2014-10-14
37451SUPPL2014-03-04
28371SUPPL2014-02-28
37450SUPPL2013-10-31
5978SUPPL2013-10-28
28370SUPPL2012-11-06
5977SUPPL2012-11-06
37449SUPPL2012-11-02
15981SUPPL2012-11-02
42270SUPPL2012-06-06
15980SUPPL2012-03-06
5976SUPPL2012-02-29
5975SUPPL2012-01-30
37448SUPPL2012-01-25
28369SUPPL2011-12-05
15979SUPPL2011-12-02
28368SUPPL2011-10-12
15978SUPPL2011-10-12
28367SUPPL2011-06-08
15977SUPPL2011-06-08
15974SUPPL2011-06-08
5973SUPPL2011-06-08
28366SUPPL2010-12-28
15976SUPPL2010-12-26
37447SUPPL2010-05-03
5974SUPPL2010-04-28
28365SUPPL2010-03-18
15975SUPPL2010-03-17
28364SUPPL2010-01-21
15973SUPPL2009-11-23
15972SUPPL2009-02-04
5972SUPPL2009-02-03
15971SUPPL2009-01-14
28363SUPPL2009-01-12
37446SUPPL2008-02-14
28362SUPPL2008-02-14
44142ORIG2008-01-25
28361SUPPL2008-01-09
15970SUPPL2007-12-14
15969SUPPL2007-05-29
5971SUPPL2007-05-29
28360SUPPL2006-12-04
15968SUPPL2006-12-04
5968SUPPL2006-10-26
37443SUPPL2006-10-25
28359SUPPL2006-10-05
15967SUPPL2006-10-05
5970SUPPL2006-07-13
37445SUPPL2006-07-05
28357SUPPL2006-03-23
5969SUPPL2006-03-23
37444SUPPL2006-03-22
15966SUPPL2006-03-22
37442SUPPL2005-12-15
28358SUPPL2005-12-15
15965SUPPL2005-10-24
37441SUPPL2005-06-07
5967SUPPL2005-06-07
37440SUPPL2005-03-10
28356SUPPL2005-03-10
28355SUPPL2005-02-17
21778ORIG2004-11-22
28354ORIG2004-07-28
15964ORIG2004-07-28
53275ORIG1900-01-01
53274ORIG1900-01-01
53273ORIG1900-01-01