Guanfacine Hydrochloride
Guanfacine Tablets, USP
Approved
Approval ID
a2759644-4e9d-4ad3-8dcd-f2a42b036332
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2010
Manufacturers
FDA
TYA Pharmaceuticals
DUNS: 938389038
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Guanfacine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64725-0711
Application NumberANDA075109
Product Classification
M
Marketing Category
C73584
G
Generic Name
Guanfacine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2010
FDA Product Classification
INGREDIENTS (4)
GUANFACINE HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: PML56A160O
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT