MedPath
FDA Approval

Fenoglide

Shore Therapeutics, Inc (DUNS: 964803477)

May 13, 2011

HUMAN PRESCRIPTION DRUG LABEL

Fenofibrate(120 mg in 1 1)

Products (2)

Fenoglide

52725-495

NDA022118

NDA (C73594)

ORAL

November 15, 2010

Code: U202363UOSClass: ACTIBQuantity: 120 mg in 1 1
Polyethylene Glycol 6000Inactive
Code: 30IQX730WEClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
Poloxamer 188Inactive
Code: LQA7B6G8JGClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT

Fenoglide

52725-490

NDA022118

NDA (C73594)

ORAL

November 15, 2010

Polyethylene Glycol 6000Inactive
Code: 30IQX730WEClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
Poloxamer 188Inactive
Code: LQA7B6G8JGClass: IACT
Code: U202363UOSClass: ACTIBQuantity: 40 mg in 1 1
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