levocetirizine dihydrochloride
These highlights do not include all the information needed to use See full prescribing information for . tablets, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
7a2ca8aa-ba0b-45b4-bdb3-651879350130
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 13, 2018
Manufacturers
FDA
Vensun Pharmaceuticals, Inc.
DUNS: 078310501
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levocetirizine dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42543-712
Application NumberANDA203646
Product Classification
M
Marketing Category
C73584
G
Generic Name
levocetirizine dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2017
FDA Product Classification
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
levocetirizine dihydrochlorideActive
Quantity: 5 mg in 1 1
Code: SOD6A38AGA
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT