MedPath
FDA Approval

Zolpidem Tartrate

March 2, 2019

Human Prescription Drug Label

Zolpidem(12.5 mg in 1 1)

Manufacturing Establishments (1)

Aphena Pharma Solutions - Tennessee, LLC

Aphena Pharma Solutions - Tennessee, LLC

128385585

Products (1)

Zolpidem Tartrate

71610-254

ANDA204170

ANDA (C73584)

ORAL

March 26, 2019

ZolpidemActive
Code: WY6W63843KClass: ACTIBQuantity: 12.5 mg in 1 1
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TARTARIC ACIDInactive
Code: W4888I119HClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
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