CLENPIQ

CLENPIQ

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Ferring Pharmaceuticals Inc.

DUNS: 103722955

Effective Date

September 5, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Picosulfuric acid(10 mg in 175 mL)

Magnesium oxide(3.5 g in 175 mL)

Citric acid(12 g in 175 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

55566-6800

Application Number

NDA209589

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

August 31, 2023

Ingredients

Picosulfuric acidActive

Code: LR57574HN8Class: ACTIBQuantity: 10 mg in 175 mL

Magnesium oxideActive

Code: 3A3U0GI71GClass: ACTIBQuantity: 3.5 g in 175 mL

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

Citric acidActive

Code: XF417D3PSLClass: ACTIBQuantity: 12 g in 175 mL

CRANBERRYInactive

Code: 0MVO31Q3QSClass: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

MALIC ACIDInactive

Code: 817L1N4CKPClass: IACT

ACESULFAME POTASSIUMInactive

Code: 23OV73Q5G9Class: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3CClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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CLENPIQ

FDA Approval Summary

Products1

CLENPIQ

Product Details