MedPath
FDA Approval

Metformin Hydrochloride

March 13, 2015

HUMAN PRESCRIPTION DRUG LABEL

Metformin(500 mg in 1 1)

Registrants (1)

Blenheim Pharmacal, Inc.

171434587

Manufacturing Establishments (1)

Blenheim Pharmacal, Inc.

Blenheim Pharmacal, Inc.

Blenheim Pharmacal, Inc.

171434587

Products (2)

Metformin Hydrochloride

10544-068

ANDA075978

ANDA (C73584)

ORAL

March 13, 2015

HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1

Metformin Hydrochloride

10544-067

ANDA075978

ANDA (C73584)

ORAL

March 13, 2015

HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1
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