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IMODIUM A-D

NDA

LOPERAMIDE HYDROCHLORIDE | N019487 | KENVUE BRANDS LLC

2 strengths0 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain6 active DMFs4 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVLOPERAMIDE HYDROCHLORIDE

DMF 73401988

PMC ISOCHEMLOPERAMIDE HYDROCHLORIDE

DMF 74531988

OLON SPALOPERAMIDE HYDROCHLORIDE

DMF 100281992

OLON SPALOPERAMIDE HYDROCHLORIDE

DMF 105171993

VASUDHA PHARMA CHEM LTDLOPERAMIDE HYDROCHLORIDE USP

DMF 277312013

VAMSI LABS LTDLOPERAMIDE HYDROCHLORIDE USP

DMF 425912025

SIFAVITOR SPAInactiveLOPERAMIDE HYDROCHLORIDE

DMF 72991988

SIPSY CHIMIE FINE SCAInactiveLOPERAMIDE HYDROCHLORIDE

DMF 80511989

LANZ LABORATORIESInactiveLOPERAMIDE HYDROCHLORIDE

DMF 83141989

JANSSEN PHARMACEUTICA NVInactiveLOPERAMIDE HYDROCHLORIDE

DMF 109421994

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Aug 13, 2019	SUPPL -34	View Letter (PDF)
Apr 14, 2017	SUPPL -32	View Letter (PDF)
Apr 7, 2016	SUPPL -28	View Letter (PDF)
Mar 19, 2015	SUPPL -27	View Letter (PDF)
Jun 9, 2005	SUPPL -23	View Letter (PDF)
Jul 14, 2004	SUPPL -22	View Letter (PDF)
Jun 16, 2004	SUPPL -21	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1MG/5ML

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Mar 1, 1988

No patent or exclusivity listings for this strength.

#002 — 1MG/7.5ML

RLD

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Jul 8, 2004