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COLESTIPOL HYDROCHLORIDE

ANDA

COLESTIPOL HYDROCHLORIDE | A077277 | IMPAX LABORATORIES INC

2 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 2 - COLESTID PI FLAVORED COLESTID- colestipol hydrochloride granul... FDA-2021-P-0513 · 6 docket documents Hyman, Phelps & McNamara P.C., on behalf of Pharmacia and Upjohn Company LLC, filed a suitability petition regarding Flavored COLESTID (colestipol hydrochloride granule, for suspension), seeking FDA assessment of the proposed formulation's suitability for approval under applicable regulatory pathway	Suitability	2021-05-27	Denied	Hyman, Phelps & McNamara P.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain6 active DMFs

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

FORMOSA LABORATORIES INCCOLESTIPOL HYDROCHLORIDE

DMF 176512004

SOLARA ACTIVE PHARMA SCIENCES LTDCOLESTIPOL HYDROCHLORIDE USP

DMF 334232018

ZYDUS LIFESCIENCES LTDCOLESTIPOL HYDROCHLORIDE USP

DMF 334602019

RISING PHARMA HOLDING INCCOLESTIPOL HYDROCHLORIDE (POVIDONE PREMIX)

DMF 335422019

RAKS PHARMA PVT LTDCOLESTIPOL HYDROCHLORIDE USP

DMF 380262023

SUN PHARMACEUTICAL INDUSTRIES LTDCOLESTIPOL HYDROCHLORIDE USP

DMF 394132024

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 3, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 5GM/SCOOPFUL

0 patents0 exclusivities▴

GRANULE;ORAL | Approved: May 2, 2006

No patent or exclusivity listings for this strength.

#002 — 5GM/PACKET

0 patents0 exclusivities▾

GRANULE;ORAL | Approved: May 2, 2006