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IMODIUM MULTI-SYMPTOM RELIEF

NDA

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | N021140 | KENVUE BRANDS LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Jun 17, 2026	SUPPL -39	View Letter (PDF)
Dec 20, 2018	SUPPL -26	View Letter (PDF)
Apr 14, 2017	SUPPL -25	View Letter (PDF)
Mar 19, 2015	SUPPL -20	View Letter (PDF)
May 8, 2012	SUPPL -16	View Letter (PDF)
May 5, 2008	SUPPL -11	View Letter (PDF)
Feb 7, 2008	SUPPL -13	View Letter (PDF)
Sep 25, 2007	SUPPL -12	View Letter (PDF)
Jun 16, 2004	SUPPL -3	View Letter (PDF)
Jun 7, 2004	SUPPL -2	View Letter (PDF)
Nov 29, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MG;125MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 30, 2000

No patent or exclusivity listings for this strength.