FDA.reportPublic FDA data

Application 021563

Type
NDA
Sponsor
SCHERING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLARINEXDESLORATADINESYRUP; ORAL0.5MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58020SUPPL2019-03-18
58016SUPPL2019-03-18
57900SUPPL2019-03-05
57888SUPPL2019-03-04
15779SUPPL2014-04-25
5739SUPPL2014-04-24
37227SUPPL2012-07-27
28118SUPPL2010-12-28
21735ORIG2006-07-10
28117ORIG2004-09-03
15778ORIG2004-09-03