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ONFI

NDA

CLOBAZAM | N203993 | LUNDBECK PHARMACEUTICALS 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 Chain9 active DMFs1 inactive

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

EUROAPI GERMANY GMBHCLOBAZAM

DMF 183402005

FIS FABBRICA ITALIANA SINTETICI SPACLOBAZAM

DMF 247282011

CAMBREX PROFARMACO MILANO SRLCLOBAZAM

DMF 290612015

PIRAMAL PHARMA LTDCLOBAZAM

DMF 291642015

HONOUR LAB LTDCLOBAZAM

DMF 293512015

CENTAUR PHARMACEUTICALS PRIVATE LTDCLOBAZAM USP

DMF 294072015

RAKS PHARMA PVT LTDCLOBAZAM

DMF 305402016

MSN LIFE SCIENCES PRIVATE LTDCLOBAZAM

DMF 308752016

MICRO LABS LTDCLOBAZAM

DMF 320592017

FIS FABBRICA ITALIANA SINTETICI SPAInactiveCLOBAZAM

DMF 180802005

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

Approval Letters

8 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 2.5MG/ML

RLDAB

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Dec 14, 2012

No patent or exclusivity listings for this strength.