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WELCHOL

NDA

COLESEVELAM HYDROCHLORIDE | N210895 | COSETTE 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 Chain8 active DMFs4 inactive

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

FORMOSA LABORATORIES INCCOLESEVELAM HYDROCHLORIDE

DMF 228702009

SOLARA ACTIVE PHARMA SCIENCES LTDCOLESEVELAM HYDROCHLORIDE

DMF 233782009

EMCURE PHARMACEUTICALS LTDCOLESEVELAM HYDROCHLORIDE

DMF 269342013

PATHEON AUSTRIA GMBH AND CO KGCOLESEVELAM HYDROCHLORIDE

DMF 289452014

FORMOSA LABORATORIES INCCOLESEVELAM HYDROCHLORIDE

DMF 300012015

APITORIA PHARMA PRIVATE LTDCOLESEVELAM HYDROCHLORIDE

DMF 310952016

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDCOLESEVELAM HYDROCHLORIDE

DMF 374312022

NAVINTA LLCCOLESEVELAM HYDROCHLORIDE

DMF 386052023

LUPIN LTDInactiveCOLESEVELAM HYDROCHLORIDE

DMF 233332010

USV LTDInactiveCOLESEVELAM HYDROCHLORIDE

DMF 256962012

IND SWIFT LABORATORIES LTDInactiveCOLESEVELAM HYDROCHLORIDE

DMF 268132013

CTX LIFE SCIENCES PVT LTDInactiveCOLESEVELAM HYDROCHLORIDE

DMF 274922013

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 13, 2020	SUPPL -1	View Letter (PDF)
Sep 3, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3.75GM

RLD

0 patents0 exclusivities▴

BAR, CHEWABLE;ORAL | Approved: Apr 3, 2019

No patent or exclusivity listings for this strength.