Registrants (1)
Sun Pharmaceutical Industries, Inc.
621633481
Manufacturing Establishments (1)
Sun Pharmaceutical Industries, Inc.
Caraco Pharmaceutical Laboratories, Ltd.
Sun Pharmaceutical Industries, Inc.
621633481
Products (3)
HydrOXYzine hydrochloride
57664-112
ANDA040899
ANDA (C73584)
ORAL
February 4, 2010
HydroxyzineActive
Code: 76755771U3Class: ACTIBQuantity: 10 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HydrOXYzine hydrochloride
57664-113
ANDA040899
ANDA (C73584)
ORAL
February 4, 2010
HydroxyzineActive
Code: 76755771U3Class: ACTIBQuantity: 25 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HydrOXYzine hydrochloride
57664-114
ANDA040899
ANDA (C73584)
ORAL
February 4, 2010
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
HydroxyzineActive
Code: 76755771U3Class: ACTIBQuantity: 50 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT