MedPath
FDA Approval

GLYBURIDE

January 13, 2021

HUMAN PRESCRIPTION DRUG LABEL

Glyburide(5 mg in 1 1)

Products (3)

GLYBURIDE

75834-204

ANDA203379

ANDA (C73584)

ORAL

January 13, 2021

GlyburideActive
Code: SX6K58TVWCClass: ACTIBQuantity: 5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT

GLYBURIDE

75834-203

ANDA203379

ANDA (C73584)

ORAL

January 13, 2021

GlyburideActive
Code: SX6K58TVWCClass: ACTIBQuantity: 2.5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT

GLYBURIDE

75834-202

ANDA203379

ANDA (C73584)

ORAL

January 13, 2021

GlyburideActive
Code: SX6K58TVWCClass: ACTIBQuantity: 1.25 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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