Registrants (1)
Novel Laboratories, Inc.
793518643
Manufacturing Establishments (1)
Novel Laboratories, Inc.
Novel Laboratories, Inc.
Novel Laboratories, Inc.
793518643
Products (1)
Moxifloxacin Hydrochloride
40032-034
ANDA207285
ANDA (C73584)
ORAL
December 21, 2019
MoxifloxacinActive
Code: C53598599TClass: ACTIMQuantity: 400 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT