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FDA Approval

Cetirizine Hydrochloride

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

FDA Approval Summary

Company
Effective Date
February 21, 2017
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cetirizine(1 mg in 1 mL)

Products1

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

Cetirizine Hydrochloride

Product Details

NDC Product Code
53217-163
Application Number
ANDA078488
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 21, 2017
Code: 64O047KTOAClass: ACTIBQuantity: 1 mg in 1 mL
BANANAInactive
Code: 4AJZ4765R9Class: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
GRAPEInactive
Code: 6X543N684KClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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