Registrants (1)
ABHAI, LLC.
079385868
Manufacturing Establishments (1)
KVK-Tec, Inc.
KVK-Tech, Inc.
ABHAI, LLC.
173360061
Products (1)
Ursodiol
10702-237
ANDA210707
ANDA (C73584)
ORAL
November 9, 2020
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
UrsadiolActive
Code: 3D089V7L0KClass: ACTIMQuantity: 300 mg in 1 1
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT