MedPath
FDA Approval

Ursodiol

September 25, 2023

HUMAN PRESCRIPTION DRUG LABEL

Ursodeoxycholic acid(300 mg in 1 1)

Registrants (1)

VGYAAN Pharmaceuticals LLC

024755855

Manufacturing Establishments (1)

Aizant Drug Research Solutions PVT LTD

VGYAAN Pharmaceuticals LLC

VGYAAN Pharmaceuticals LLC

650372951

Products (1)

Ursodiol

72664-217

ANDA214329

ANDA (C73584)

ORAL

September 25, 2023

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
Code: 724L30Y2QRClass: ACTIBQuantity: 300 mg in 1 1
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