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FDA Approval

childrens allergy relief

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

FDA Approval Summary

Company
Effective Date
May 7, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Loratadine(5 mg in 1 1)

Products1

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

childrens allergy relief

Product Details

NDC Product Code
41250-629
Application Number
ANDA210033
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 7, 2025
Code: 7AJO3BO7QNClass: ACTIBQuantity: 5 mg in 1 1
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4DClass: IACT
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