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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209589
Company: FERRING PHARMS INC

Medication Guide

Products on NDA 209589

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLENPIQ	CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE	12GM/BOT;3.5GM/BOT;10MG/BOT	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209589

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/28/2017	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209589s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209589Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209589Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2023	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209589s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209589Orig1s015ltr.pdf
08/30/2022	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209589s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209589Orig1s014ltr.pdf
10/18/2019	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209589s006lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209589Orig1s006ltr.pdf
08/08/2019	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209589s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209589Orig1s005ltr.pdf

Labels for NDA 209589

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2023	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209589s015lbl.pdf
08/30/2022	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209589s014lbl.pdf
10/18/2019	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209589s006lbledt.pdf
08/08/2019	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209589s005lbl.pdf
11/28/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209589s000lbl.pdf

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