Viewing data from:

DISOMER

NDA

DEXBROMPHENIRAMINE MALEATE | N011814 | SCHERING CORP SUB SCHERING PLOUGH CORP

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 Chain1 active DMF5 inactive

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

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDDEXBROMPHENIRAMINE MALEATE

DMF 86251990

SCHERING PLOUGH AVONDALE COInactiveDEXBROMPHENIRAMINE MALEATE

DMF 43121981

INDUSTRIA CHIMICA MILANESE SPAInactiveDEXBROMPHENIRAMINE MALEATE USP. XX

DMF 47991982

HOUBA INCInactiveDEXBROMPHENIRAMINE MALEATE

DMF 55171984

ISPInactiveDEXBROMPHENIRAMINE MALEATE

DMF 56691985

GANES CHEMICALS INC PENNSVILLE DIVInactiveDEXBROMPHENIRAMINE MALEATE

DMF 76521988

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

Products (2)

Sort:

#001 — 2MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 2MG/5ML

0 patents0 exclusivities▾

SYRUP;ORAL | Approved: Approved Prior to Jan 1, 1982