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QUARZAN

NDA

CLIDINIUM BROMIDE | N010355 | HOFFMANN LA ROCHE INC

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 Chain4 active DMFs

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

OLON SPACLIDINIUM BROMIDE

DMF 28091976

RESONANCE LABORATORIES PVT LTDCLIDINIUM BROMIDE USP

DMF 247252011

MSN LABORATORIES PRIVATE LTDCLIDINIUM BROMIDE USP

DMF 326742018

RAKS PHARMA PVT LTDCLIDINIUM BROMIDE USP

DMF 351862020

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

Products (2)

Sort:

#001 — 2.5MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

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