Registrants (1)
PSS World Medical Inc.
101822682
Manufacturing Establishments (1)
STAT Rx USA LLC
STAT Rx USA LLC
PSS World Medical Inc.
786036330
Products (2)
AMBIEN
16590-010
NDA019908
NDA (C73594)
ORAL
September 18, 2012
ZolpidemActive
Code: WY6W63843KClass: ACTIBQuantity: 10 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
AMBIEN
16590-009
NDA019908
NDA (C73594)
ORAL
September 18, 2012
ZolpidemActive
Code: WY6W63843KClass: ACTIBQuantity: 5 mg in 1 1
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT