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COLESEVELAM HYDROCHLORIDE

ANDA

COLESEVELAM HYDROCHLORIDE | A202190 | GLENMARK PHARMACEUTICALS LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: WELCHOL

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

1 letter from Drugs@FDA

Date	Submission	Document
Aug 20, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 1.875GM/PACKET

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Jul 16, 2018

No patent or exclusivity listings for this strength.

#002 — 3.75GM/PACKET

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: Jul 16, 2018