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NDA

DIETHYLCARBAMAZINE CITRATE | N006459 | LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO

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 Chain1 active DMF4 inactive

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

SCL LIFESCIENCES LTDDIETHYLCARBAMAZINE CITRATE

DMF 269542013

ORGAMOL SAInactiveDIETHYLCARBAMAZINE CITRATE

DMF 30041977

BRIDGE CHEMICALSInactiveDIETHYLCARBAMAZINE CITRATE

DMF 47771982

EGIS PHARMACEUTICALS PRIVATE LTDInactiveDIETHYLCARBAMAZINE CITRATE USP

DMF 66651986

INNOVATIVE FOOD PROCESSORS INCInactiveDIETHYLCARBAMAZINE CITRATE

DMF 71891987

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

Products (1)

#001 — 50MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.