MedPath
FDA Approval

Zolpidem Tartrate

April 10, 2014

HUMAN PRESCRIPTION DRUG LABEL

Zolpidem(10 mg in 1 1)

Manufacturing Establishments (1)

Aphena Pharma Solutions - Tennessee, LLC

Aphena Pharma Solutions - Tennessee, LLC

128385585

Products (2)

Zolpidem Tartrate

43353-617

ANDA078616

ANDA (C73584)

ORAL

April 10, 2014

ZolpidemActive
Code: WY6W63843KClass: ACTIBQuantity: 10 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT

Zolpidem Tartrate

43353-620

ANDA078616

ANDA (C73584)

ORAL

April 10, 2014

ZolpidemActive
Code: WY6W63843KClass: ACTIBQuantity: 5 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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