MedPath
FDA Approval

METFORMIN HYDROCHLORIDE

April 18, 2023

HUMAN PRESCRIPTION DRUG LABEL

Metformin(850 mg in 1 1)

Manufacturing Establishments (1)

Harman Finochem Limited

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

675487429

Products (3)

METFORMIN HYDROCHLORIDE

23155-842

ANDA213320

ANDA (C73584)

ORAL

April 18, 2023

HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 850 mg in 1 1

METFORMIN HYDROCHLORIDE

23155-843

ANDA213320

ANDA (C73584)

ORAL

April 18, 2023

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1

METFORMIN HYDROCHLORIDE

23155-841

ANDA213320

ANDA (C73584)

ORAL

April 18, 2023

HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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