Viewing data from:

SUDAFED 24 HOUR

NDA

PSEUDOEPHEDRINE HYDROCHLORIDE | N020021 | 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

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

Citizen Petitions

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Eurand America Inc. FDA-1997-P-0238 · 7 docket documents Eurand America Inc. filed this petition on May 29, 1997, requesting that the FDA permit filing of an ANDA for Pseudoephedrine Hydrochloride 120mg capsules using Sudafed 12 Hour tablets as the reference product under 21 CFR 314.93(b), and requesting that the FDA determine whether the voluntarily with	505(q)	2017-05-31	Partially Denied	Eurand America Inc.
Pharma Medica - Citizen Petition FDA-2009-P-0320 · 2 docket documents Pharma Medica submitted a citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare sustained release tablets containing Chlorpheniramine maleate 8 mg and Pseudoephedrine Hydrochloride 120 mg suitable for marketing pending ANDA approval, and reque	Other	2009-07-16	Open	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

46 trials from ClinicalTrials.gov, 41 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)NCT00276016	Phase 3	Completed	Organon and Co	39	2006-01 → 2006-02
Bioequivalence Study of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets Under Fed Conditions NCT01132222	Phase 1	Completed	Dr. Reddy's Laboratories Limited	34	2004-09 → 2004-10
Evaluation of Histamine, CGRP and VIP as Markers for Activation of Trigeminal and Parasympathetic Nerve Fibers NCT00208065	Phase 4	Completed	Clinvest	50	2004-05 → 2005-11
Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra D 24 Hour ER Tablets Under Fasting Conditions NCT01133470	Phase 1	Completed	Dr. Reddy's Laboratories Limited	54	2007-02 → 2007-04
Efficacy and Safety of Sinutab on Subjects in the Setting of a Common Cold NCT00378144	Phase 4	Completed	McNeil AB	469	2007-01 → 2008-03
Study to Compare the Effect of a Combination of Cetirizine With Pseudoephedrine Versus Placebo on Symptoms in Patients With Allergic Rhinitis Within/Out of Season NCT00474890	N/A	Completed	Fraunhofer-Institute of Toxicology and Experimental Medicine	70	2007-06 → 2008-02
TransMEM Gas Exchange -- Project 1, Aim 2 NCT01925729	Phase 1	Completed	Cuneyt M. Alper	84	2013-10-01 → 2019-03-22
Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in Healthy Subjects NCT02963701	Phase 1	Completed	Boehringer Ingelheim	56	2016-12-20 → 2017-02-08
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fasting Conditions NCT00881127	Phase 1	Completed	Sandoz	40	2005-07 → 2005-07
Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fed Conditions NCT01131767	Phase 1	Completed	Dr. Reddy's Laboratories Limited	26	2004-07 → 2004-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain3 active DMFs8 inactive

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

EMBIO LTDPSEUDOEPHEDRINE HYDROCHLORIDE, USP

DMF 139481998

CHENG FONG CHEMICAL CO LTDPSEUDOEPHEDRINE HYDROCHLORIDE

DMF 169772003

ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTDPSEUDOEPHEDRINE HYDROCHLORIDE USP

DMF 182712005

H REISMAN CORPInactivePSEUDOEPHEDRINE HYDROCHLORIDE AS PROCESSED IN THE ORANGE, NJ FACILITY

DMF 47831982

H REISMAN CORPInactivePSEUDOEPHEDRINE HYDROCHLORIDE

DMF 70701987

BURROUGHS WELLCOME INDIA LTDInactivePSEUDOEPHEDRINE HYDROCHLORIDE

DMF 94841992

WYCKOFF CHEMICAL CO INCInactivePSEUDOEPHEDRINE HYDROCHLORIDE

DMF 98211992

XINJIANG HESHUO PHARMACEUTICAL COMPLEXInactivePSEUDOEPHEDRINE HYDROCHLORIDE, MANFACTURED AT XINJIANG HESHUO EPHEDRINE FACTORY IN HESHUO XINJIANG, CHINA

DMF 122301996

XINJIANG HESHUO EPHEDRINE PRODUCT CO LTDInactivePSEUDOEPHEDRINE HYDROCHLORIDE

DMF 153322001

AVON ORGANICS LTDInactivePSEUDOEPHEDRINE HYDROCHLORIDE

DMF 155242001

CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO LTDInactivePSEUDOEPHEDRINE HYDROCHLORIDE

DMF 175182004

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 7, 2018	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 240MG

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 15, 1992

No patent or exclusivity listings for this strength.