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CHLOROMYCETIN

NDA

CHLORAMPHENICOL | N050205 | PARKEDALE PHARMACEUTICALS 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 Chain2 active DMFs12 inactive

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

QUIMICA SINTETICA SACHLORAMPHENICOL

DMF 89351990

MAHIMA LIFE SCIENCES PRIVATE LTDCHLORAMPHENICOL PALMITATE USP

DMF 278862013

QUIMICA SINTETICA SAInactiveCHLORAMPHENICOL PALMITATE

DMF 88531990

PARKE DAVIS DIV WARNER LAMBERT COInactiveCHLORAMPHENICOL

DMF 133351998

RACHELLE LABORATORIES INCInactiveCHLORAMPHENICOL

DMF 133081998

PARKE DAVIS DIV WARNER LAMBERT COInactiveCHLORAMPHENICOL PALMITATE

DMF 133511998

FARMITALIA CARLO ERBA SPAInactiveCHLORAMPHENICOL

DMF 134141998

FARMITALIA CARLO ERBA SPAInactiveCHLORAMPHENICOL PALMITATE

DMF 134151998

FLAVINE INTERNATIONAL INCInactiveCHLORAMPHENICOL

DMF 135501998

ROXANE LABORATORIES INCInactiveCHLORAMPHENICOL

DMF 135791998

PHILIPS ROXANE INCInactiveCHLORAMPHENICOL

DMF 136181998

EGIS PHARMACEUTICALS PRIVATE LTDInactiveCHLORAMPHENICOL

DMF 136321998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveCHLORAMPHENICOL HEMISUCCINATE

DMF 173732004

FRESENIUS KABI ONCOLOGY LTDInactiveCHLORAMPHENICOL HEMISUCCINATE

DMF 278062014

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

Products (1)

#001 — 0.5%

0 patents0 exclusivities▴

SOLUTION/DROPS;OTIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.