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FDA Approval

CLENPIQ

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

FDA Approval Summary

Company
Effective Date
October 26, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Magnesium oxide(3.5 g in 160 mL)
Picosulfuric acid(10 mg in 160 mL)
Citric acid(12 g in 160 mL)

Manufacturing Establishments6

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Jungbunzlauer Ladenburg GmbH

Ferring Pharmaceuticals Inc.

322121609

Ferring Production Inc.

Ferring Pharmaceuticals Inc.

079510999

Tomita Phamaceutical Co., Ltd.

Ferring Pharmaceuticals Inc.

690643499

ASM Aerosol-Service AG

Ferring Pharmaceuticals Inc.

480286111

F.M. Howell & Company

Ferring Pharmaceuticals Inc.

962888116

Cambrex Profarmaco Milano S.R.L.

Ferring Pharmaceuticals Inc.

438051401

Products1

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

CLENPIQ

Product Details

NDC Product Code
55566-6700
Application Number
NDA209589
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 31, 2019
Code: 3A3U0GI71GClass: ACTIBQuantity: 3.5 g in 160 mL
Code: LR57574HN8Class: ACTIBQuantity: 10 mg in 160 mL
Code: XF417D3PSLClass: ACTIBQuantity: 12 g in 160 mL
CRANBERRYInactive
Code: 0MVO31Q3QSClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
MALIC ACIDInactive
Code: 817L1N4CKPClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9Class: IACT
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