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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212102
Company: UCB INC

Medication Guide

REMS

Products on NDA 212102

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FINTEPLA	FENFLURAMINE HYDROCHLORIDE	EQ 2.2MG BASE/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212102

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/25/2020	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212102s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212102Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212102Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2024	SUPPL-14	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212102Orig1s014ltr.pdf
12/11/2023	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212102s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212102Orig1s013ltr.pdf
05/30/2023	SUPPL-9	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212102Orig1s009ltr.pdf
09/14/2023	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212102s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212102Orig1s007,s008ltr.pdf
09/14/2023	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212102s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212102Orig1s007,s008ltr.pdf
01/03/2023	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212102s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212102Orig1s006ltr.pdf
06/15/2022	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212102s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212102Orig1s005ltr.pdf
03/25/2022	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212102s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212102Orig1s003ltr.pdf

Labels for NDA 212102

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212102s013lbl.pdf
09/14/2023	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212102s007s008lbl.pdf
09/14/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212102s007s008lbl.pdf
09/14/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212102s007s008lbl.pdf
09/14/2023	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212102s007s008lbl.pdf
01/03/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212102s006lbl.pdf
06/15/2022	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212102s005lbl.pdf
03/25/2022	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212102s003lbl.pdf
06/25/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212102s000lbl.pdf

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