MedPath
FDA Approval

FORTAMET

November 30, 2018

HUMAN PRESCRIPTION DRUG LABEL

Metformin(500 mg in 1 1)

Products (2)

FORTAMET

59630-574

NDA021574

NDA (C73594)

ORAL

November 30, 2018

FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1
CANDELILLA WAXInactive
Code: WL0328HX19Class: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6Class: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT

FORTAMET

59630-575

NDA021574

NDA (C73594)

ORAL

November 30, 2018

HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
CANDELILLA WAXInactive
Code: WL0328HX19Class: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
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