FDA.reportPublic FDA data

Application 078353

Type
ANDA
Sponsor
ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESLORATADINEDESLORATADINETABLET; ORAL5MGNoNo

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 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
brand name: Desloratadine
generic name: DESLORATADINE
DESLORATADINEDESLORATADINELupin Pharmaceuticals, Inc.2a90b899-7746-43dc-ac8a-e754428eb30c2026-06-30Warnings, Adverse reactionsName fallback
brand name: DESLORATADINE
generic name: DESLORATADINE
DESLORATADINEDESLORATADINEBryant Ranch Prepackf84c8de3-a7d3-4e8b-bfb6-04259e79450a2026-06-01Warnings, Adverse reactionsName fallback
brand name: DESLORATADINE
generic name: DESLORATADINE
DesloratadineDESLORATADINENatco Pharma USA LLCe4db30a5-48e5-4fe3-8793-30b6866f87c12026-04-23Warnings, Adverse reactionsName fallback
brand name: Desloratadine
generic name: DESLORATADINE
DESLORATADINEDESLORATADINEA-S Medication Solutionsa3b61ab9-ec20-4831-b69a-fcd913fce5402026-04-16Warnings, Adverse reactionsName fallback
brand name: DESLORATADINE
generic name: DESLORATADINE
DESLORATADINEDESLORATADINEA-S Medication Solutions69b9635b-c790-4316-a790-67b0f5512b722026-04-16Warnings, Adverse reactionsName fallback
brand name: DESLORATADINE
generic name: DESLORATADINE
DesloratadineDESLORATADINEBryant Ranch Prepackcf7f838b-4595-4c81-97b9-e1594347e1bd2025-11-06Warnings, Adverse reactionsName fallback
brand name: Desloratadine
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
brand name: Desloratadine
generic name: DESLORATADINE
ClarinexDESLORATADINEOrganon LLCc671342e-69a2-4ca5-abc2-8166ed4240d42025-05-17Warnings, Adverse reactionsName fallback
generic name: DESLORATADINE
DesloratadineDESLORATADINEDr. Reddy's Laboratories Limitede5d1f465-e436-b4fd-d351-07a7b2acb4402024-02-28Warnings, Adverse reactionsName fallback
brand name: Desloratadine
generic name: DESLORATADINE
DesloratadineDESLORATADINEA-S Medication Solutions36307c2b-6b6a-46a9-9fe4-1798fc72e7b82023-12-12Warnings, Adverse reactionsName fallback
brand name: Desloratadine
generic name: DESLORATADINE
DesloratadineDESLORATADINEBionpharma Inc.4d094001-b85a-47b3-bc67-a46660384ece2023-11-27Warnings, Adverse reactionsName fallback
brand name: Desloratadine
generic name: DESLORATADINE

Reported adverse events (FAERS/openFDA)#

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