An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
10/15/2025	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212102s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212102Orig1s017ltr.pdf
04/08/2025	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212102s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212102Orig1s016ltr.pdf
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-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
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
10/15/2025	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212102s017lbl.pdf
04/08/2025	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212102s016lbl.pdf
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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212102s007s008lbl.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-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

Top