Application 021445

Type
NDA
Sponsor
MSD INTL GMBH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZETIAEZETIMIBETABLET;ORAL10MGYesYes

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

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
N021445-001ZETIAEZETIMIBE10MGTABLET / ORALABRLD, RS2002-10-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021445-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021445-00176120582025-10-30U-1027
N021445-00176120582025-10-30U-1173
N021445-0017612058*PED2026-04-30Pediatric extension

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-2587673890dc5c…
2021-03-12 10:30 UTC2021-03N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-253f01610625f2…
2019-09-15 20:21 UTC2019-09N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25b00525d2431f…
2019-07-19 19:46 UTC2019-07N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-253f0d92c62455…
2023-05-13 08:27 UTC2023-05N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25053a50430f4f…
2023-01-26 05:58 UTC2023-01N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021445-001ZETIA10MGTABLET / ORALABRLD, RS2002-10-25cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021445-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021445-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021445-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021445-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021445-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021445-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021445-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021445-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021445-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021445-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021445-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021445-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021445-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021445-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021445-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021445-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021445-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021445-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021445-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021445-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021445-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021445-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021445-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021445-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021445-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021445-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021445-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021445-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021445-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021445-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021445-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021445-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021445-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021445-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021445-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021445-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021445-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021445-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021445-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021445-001AB1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 4 · 159 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021445-00176120582025-10-30U-1173011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021445-00176120582025-10-30U-1027011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021445-0017612058*PED2026-04-30Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021445-00176120582025-10-30U-117331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021445-00176120582025-10-30U-102731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021445-0017612058*PED2026-04-30Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N021445-00176120582025-10-30U-11736a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021445-00176120582025-10-30U-10276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021445-0017612058*PED2026-04-30Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021445-00176120582025-10-30U-1173fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021445-00176120582025-10-30U-1027fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021445-0017612058*PED2026-04-30Pediatric extensionfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021445-00176120582025-10-30U-1173b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021445-00176120582025-10-30U-1027b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021445-0017612058*PED2026-04-30Pediatric extensionb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021445-00176120582025-10-30U-117303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021445-00176120582025-10-30U-102703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021445-0017612058*PED2026-04-30Pediatric extension03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021445-00176120582025-10-30U-11732680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021445-00176120582025-10-30U-10272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021445-0017612058*PED2026-04-30Pediatric extension2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021445-00176120582025-10-30U-11735bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021445-00176120582025-10-30U-10275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021445-0017612058*PED2026-04-30Pediatric extension5bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021445-00176120582025-10-30U-1173d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021445-00176120582025-10-30U-1027d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021445-0017612058*PED2026-04-30Pediatric extensiond8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021445-00176120582025-10-30U-1173d06236e962d9…
2024-10-29 15:01 UTC2024-10N021445-00176120582025-10-30U-1027d06236e962d9…
2024-10-29 15:01 UTC2024-10N021445-0017612058*PED2026-04-30Pediatric extensiond06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021445-00176120582025-10-30U-117379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021445-00176120582025-10-30U-102779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021445-0017612058*PED2026-04-30Pediatric extension79d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021445-00176120582025-10-30U-1173301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021445-00176120582025-10-30U-1027301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021445-0017612058*PED2026-04-30Pediatric extension301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021445-00176120582025-10-30U-11731e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021445-00176120582025-10-30U-10271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021445-0017612058*PED2026-04-30Pediatric extension1e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021445-00176120582025-10-30U-11738072bd15b7f6…

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
ZetiaEZETIMIBEOrganon LLC174e45e0-45bb-48b7-9e60-8f6cfc1d22bb2025-11-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 021445
application number: NDA021445
ndc (product): 78206-178

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-778ZetiaEzetimibeRebel Distributors CorpNDACurrent
50090-0833ZetiaEzetimibeA-S Medication SolutionsNDACurrent
55154-5031ZetiaEzetimibeCardinal HealthNDACurrent
55154-5034ZetiaEzetimibeCardinal HealthNDACurrent
55154-5043ZetiaEzetimibeCardinal HealthNDACurrent
66582-414ZetiaEzetimibeMerck Sharp & Dohme Corp.NDACurrent
66582-414ZetiaEzetimibeMerck Sharp & Dohme Corp.NDACurrent
66582-414ZetiaEzetimibeMerck Sharp & Dohme Corp.NDACurrent
66582-414ZetiaEzetimibeMerck Sharp & Dohme Corp.NDACurrent
78206-178ZetiaEzetimibeOrganon LLCNDACurrent
78206-178ZetiaEzetimibeOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77598SUPPL 2024-02-22
77592SUPPL 2024-02-22
76738SUPPL 2023-12-05
74850SUPPL 2023-07-21
74842SUPPL 2023-07-21
68319SUPPL2021-08-09
68318SUPPL2021-08-09
36956SUPPL2014-10-30
27816SUPPL2014-10-14
27815SUPPL2012-01-30
15498SUPPL2012-01-25
15497SUPPL2011-08-12
5410SUPPL2011-08-12
27814SUPPL2009-11-25
5409SUPPL2009-11-25
15496SUPPL2009-07-23
15495SUPPL2009-07-23
36955SUPPL2009-02-04
5408SUPPL2009-02-04
36954SUPPL2008-06-12
15494SUPPL2008-06-12
27813SUPPL2008-06-09
5407SUPPL2008-06-09
42173SUPPL2008-02-19
21664SUPPL2008-02-19
21663SUPPL2008-02-19
15493SUPPL2008-02-14
5406SUPPL2008-02-13
44124ORIG2008-01-25
27812SUPPL2008-01-09
15492SUPPL2007-12-14
15491SUPPL2006-11-06
5405SUPPL2006-11-06
5402SUPPL2006-05-25
36951SUPPL2006-05-24
5404SUPPL2006-03-23
5401SUPPL2006-03-23
36953SUPPL2006-03-22
15490SUPPL2006-03-22
5403SUPPL2006-01-30
36952SUPPL2006-01-27
15489SUPPL2005-03-29
5400SUPPL2005-03-29
36950SUPPL2005-03-10
27811SUPPL2005-03-10
51734SUPPL2004-11-23
27810SUPPL2004-09-27
36949SUPPL2004-07-28
36948SUPPL2004-07-28
27809SUPPL2004-07-28
27808SUPPL2004-07-28
15488SUPPL2004-07-28
5399SUPPL2004-07-28
21662ORIG2003-02-03
27807ORIG2002-10-25
15487ORIG2002-10-25
63917ORIG1900-01-01
53278ORIG1900-01-01
53277ORIG1900-01-01
53276ORIG1900-01-01