URSODIOL
Ursodiol Capsules USPRevised: August 2008 2000700-00
Approved
Approval ID
35e3194c-ba8b-4b0d-96a6-e2c77e98fda4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 14, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
URSODIOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-349
Application NumberNDA019594
Product Classification
M
Marketing Category
C73594
G
Generic Name
URSODIOL
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2010
FDA Product Classification
INGREDIENTS (7)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
URSODIOLActive
Quantity: 300 mg in 1 1
Code: 724L30Y2QR
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDEInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT