Application 021312

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLARINEXDESLORATADINETABLET, ORALLY DISINTEGRATING;ORAL5MGYesYes
002CLARINEXDESLORATADINETABLET, ORALLY DISINTEGRATING;ORAL2.5MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021312-001CLARINEXDESLORATADINE5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-26
N021312-002CLARINEXDESLORATADINE2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-14

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-2684e616aacf4f…
2026-09-14 22:38:342026-08N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-1484e616aacf4f…
2026-08-18 06:07:402026-07N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021312-001CLARINEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021312-002CLARINEX2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021312-001CLARINEX5MGTABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021312-002CLARINEX2.5MGTABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021312-001CLARINEX5MGTABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021312-002CLARINEX2.5MGTABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021312-001CLARINEX5MGTABLET, ORALLY DISINTEGRATING / ORALRLD2002-06-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021312-002CLARINEX2.5MGTABLET, ORALLY DISINTEGRATING / ORALRLD2005-07-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021312-001CLARINEX5MGTABLET, ORALLY DISINTEGRATING / ORALABRLD, RS2002-06-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021312-002CLARINEX2.5MGTABLET, ORALLY DISINTEGRATING / ORALABRLD2005-07-1474a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N021312-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021312-002AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021312-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021312-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021312-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021312-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021312-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N021312-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021312-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N021312-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021312-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N021312-002AB1ea99ee380514…

Observed Orange Book patent history#

Patent history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021312-00161002742019-07-07Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021312-0016100274*PED2020-01-07Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021312-00176186492020-12-19U-1017Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021312-0017618649*PED2021-06-19Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021312-00261002742019-07-07Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021312-0026100274*PED2020-01-07Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021312-00276186492020-12-19U-1017Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021312-0027618649*PED2021-06-19Pediatric extension74a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021312-0017618649*PED2021-06-19Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021312-0027618649*PED2021-06-19Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021312-0017618649*PED2021-06-19Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021312-0027618649*PED2021-06-19Pediatric extension87673890dc5c…
2021-03-12 10:30 UTC2021-03N021312-0017618649*PED2021-06-19Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021312-0027618649*PED2021-06-19Pediatric extension5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021312-0016100274*PED2020-01-07Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021312-00176186492020-12-19U-1017Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021312-0017618649*PED2021-06-19Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021312-0026100274*PED2020-01-07Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021312-00276186492020-12-19U-1017Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021312-0027618649*PED2021-06-19Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021312-0016100274*PED2020-01-07Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021312-00176186492020-12-19U-1017Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021312-0017618649*PED2021-06-19Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021312-0026100274*PED2020-01-07Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021312-00276186492020-12-19U-1017Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021312-0027618649*PED2021-06-19Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021312-00161002742019-07-07Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021312-0016100274*PED2020-01-07Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021312-00176186492020-12-19U-1017Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021312-0017618649*PED2021-06-19Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021312-00261002742019-07-07Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021312-0026100274*PED2020-01-07Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021312-00276186492020-12-19U-1017Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021312-0027618649*PED2021-06-19Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021312-00161002742019-07-07Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021312-0016100274*PED2020-01-07Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N021312-00176186492020-12-19U-1017Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021312-0017618649*PED2021-06-19Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N021312-00261002742019-07-07Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021312-0026100274*PED2020-01-07Pediatric extensionb00525d2431f…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesloratadineDESLORATADINEMorepen Bio Inc.21174c0f-9204-4c75-b6e6-2f9ada5b535d2026-08-26Warnings, Adverse reactionsName fallback
generic name: DESLORATADINE
DESLORATADINEDESLORATADINELupin Pharmaceuticals, Inc.2a90b899-7746-43dc-ac8a-e754428eb30c2026-06-30Warnings, Adverse reactionsName fallback
generic name: DESLORATADINE
DESLORATADINEDESLORATADINEBryant Ranch Prepackf84c8de3-a7d3-4e8b-bfb6-04259e79450a2026-06-01Warnings, Adverse reactionsName fallback
generic name: DESLORATADINE
DesloratadineDESLORATADINENatco Pharma USA LLCe4db30a5-48e5-4fe3-8793-30b6866f87c12026-04-23Warnings, Adverse reactionsName fallback
generic name: DESLORATADINE
DESLORATADINEDESLORATADINEA-S Medication Solutionsa3b61ab9-ec20-4831-b69a-fcd913fce5402026-04-16Warnings, Adverse reactionsName fallback
generic name: DESLORATADINE
DESLORATADINEDESLORATADINEA-S Medication Solutions69b9635b-c790-4316-a790-67b0f5512b722026-04-16Warnings, Adverse reactionsName fallback
generic name: DESLORATADINE
DesloratadineDESLORATADINEBryant Ranch Prepackcf7f838b-4595-4c81-97b9-e1594347e1bd2025-11-06Warnings, Adverse reactionsName fallback
generic name: DESLORATADINE
Desloratadine Oral SolutionDESLORATADINEINA Pharmaceutics, Inc.41d5e0d4-6188-847b-e063-6294a90a2e2f2025-10-23Warnings, Adverse reactionsName fallback
generic name: DESLORATADINE
DesloratadineDESLORATADINEVirtus Pharmaceuticals, LLC0fe374d0-c14b-4102-b568-eb79165fc7ef2025-07-10Warnings, Adverse reactionsName fallback
generic name: DESLORATADINE
ClarinexDESLORATADINEOrganon LLCc671342e-69a2-4ca5-abc2-8166ed4240d42025-05-17Warnings, Adverse reactionsName fallback
brand name: Clarinex
generic name: DESLORATADINE
DesloratadineDESLORATADINEDr. Reddy's Laboratories Limitede5d1f465-e436-b4fd-d351-07a7b2acb4402024-02-28Warnings, Adverse reactionsName fallback
generic name: DESLORATADINE
DesloratadineDESLORATADINEA-S Medication Solutions36307c2b-6b6a-46a9-9fe4-1798fc72e7b82023-12-12Warnings, Adverse reactionsName fallback
generic name: DESLORATADINE
DesloratadineDESLORATADINEBionpharma Inc.4d094001-b85a-47b3-bc67-a46660384ece2023-11-27Warnings, Adverse reactionsName fallback
generic name: DESLORATADINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58021SUPPL2019-03-18
58015SUPPL2019-03-18
57899SUPPL2019-03-05
57887SUPPL2019-03-04
36634SUPPL2014-04-25
27454SUPPL2014-04-24
21592SUPPL2011-02-15
5001SUPPL2010-12-28
27453SUPPL2006-12-28
27452SUPPL2006-12-28
5000SUPPL2006-12-28
15164SUPPL2006-12-26
15165SUPPL2005-07-21
4999SUPPL2005-07-21
4998SUPPL2004-06-01
27451SUPPL2004-02-03
42092ORIG2003-11-06
27450ORIG2002-06-26
15163ORIG2002-06-26