MedPath
FDA Approval

Metformin Hydrochloride

June 25, 2014

HUMAN PRESCRIPTION DRUG LABEL

Metformin(1000 mg in 1 1)

Manufacturing Establishments (1)

Aphena Pharma Solutions - Tennessee, LLC

Aphena Pharma Solutions - Tennessee, LLC

128385585

Products (3)

Metformin Hydrochloride

43353-349

ANDA075985

ANDA (C73584)

ORAL

June 25, 2014

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
POVIDONESInactive
Code: FZ989GH94EClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

Metformin Hydrochloride

43353-344

ANDA075985

ANDA (C73584)

ORAL

June 25, 2014

MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 850 mg in 1 1
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
POVIDONESInactive
Code: FZ989GH94EClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Metformin Hydrochloride

43353-340

ANDA075985

ANDA (C73584)

ORAL

June 25, 2014

MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POVIDONESInactive
Code: FZ989GH94EClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
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