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NDA

CHLORDIAZEPOXIDE | N017813 | VALEANT PHARMACEUTICALS INTERNATIONAL

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 Chain5 active DMFs3 inactive

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

FIS FABBRICA ITALIANA SINTETICI SPACHLORDIAZEPOXIDE HCL

DMF 4671962

CAMBREX PROFARMACO MILANO SRLCHLORDIAZEPOXIDE

DMF 61591985

CENTAUR PHARMACEUTICALS PVT LTDCHLORDIAZEPOXIDE USP

DMF 253352011

R L FINE CHEM PVT LTDCHLORDIAZEPOXIDE

DMF 339722019

CENTAUR PHARMACEUTICALS PVT LTDCHLORDIAZEPOXIDE HCL USP

DMF 357942021

PHENCHEM INDUSTRIES LTDInactiveCHLORDIAZEPOXIDE HCL USP (DMF FORMERLY HELD BY MICRO CHEMICALS LTD)

DMF 21031973

PCR INCInactiveCHLORDIAZEPOXIDE AND CHLORDIAZEPOXIDE CHL

DMF 26721976

DRUGS INCInactiveCHLORDIAZEPOXIDE HCL

DMF 26811976

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

Products (1)

#001 — 30MG

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Sep 12, 1983

No patent or exclusivity listings for this strength.