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AFRINOL

NDA

PSEUDOEPHEDRINE SULFATE | N018191 | SCHERING PLOUGH HEALTHCARE PRODUCTS INC

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 Chain3 active DMFs4 inactive

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

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHPSEUDOEPHEDRINE SULFATE

DMF 49231983

CHENG FONG CHEMICAL CO LTDPSEUDOEPHEDRINE SULFATE

DMF 182412005

EMBIO LTDPSEUDOEPHEDRINE SULFATE USP

DMF 358612021

WYCKOFF CHEMICAL CO INCInactivePSEUDOEPHEDRINE SULFATE

DMF 104401993

EMBIO LTDInactivePSEUDOEPHEDRINE SULFATE USP

DMF 146982000

AVON ORGANICS LTDInactivePSEUDOEPHEDRINE SULFATE USP

DMF 168252003

CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO LTDInactivePSEUDOEPHEDRINE SULFATE USP

DMF 185722005

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

Products (1)

#001 — 120MG

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.