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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs7 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

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 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.