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FDA Approval

Allergy Relief

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
WinCo Foods, LLC
DUNS: 056098817
Effective Date
April 8, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Loratadine(10 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Allergy Relief

Product Details

NDC Product Code
67091-350
Application Number
ANDA075209
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 8, 2025
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
Code: 7AJO3BO7QNClass: ACTIBQuantity: 10 mg in 1 1
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