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FDA NDA · NDA209589

CLENPIQ

sodium picosulfate, magnesium oxide, and anhydrous citric acid

Sponsor: FERRING PHARMS INC

APPLICATION
NDA209589
TYPE
NDA
ORIGINAL APPROVAL
2017-11-28
LATEST ACTION
2023-08-29
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

CLENPIQ · ReferencePrescription
CITRIC ACID 12GM/BOT, MAGNESIUM OXIDE 3.5GM/BOT, SODIUM PICOSULFATE 10MG/BOT · SOLUTION · ORAL

Approval history

2023-08-29Labeling · Supplement 15 · standard — Letter ↗AP
2022-08-30Labeling · Supplement 14 · standard — Letter ↗AP
2019-10-18Efficacy · Supplement 6 · standard — Label ↗AP
2019-08-08Efficacy · Supplement 5 · standard — Label ↗AP
2017-11-28Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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