Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077277
Company: IMPAX LABS

Products on ANDA 077277

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	5GM/SCOOPFUL	GRANULE;ORAL	Prescription	AB	No	No
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	5GM/PACKET	GRANULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077277

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/02/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077277LTR.pdf

Therapeutic Equivalents for ANDA 077277

COLESTIPOL HYDROCHLORIDE

GRANULE;ORAL; 5GM/SCOOPFUL
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COLESTID	COLESTIPOL HYDROCHLORIDE	5GM/SCOOPFUL	GRANULE;ORAL	Prescription	Yes	AB	017563	PFIZER
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	5GM/SCOOPFUL	GRANULE;ORAL	Prescription	No	AB	077277	IMPAX LABS

GRANULE;ORAL; 5GM/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COLESTID	COLESTIPOL HYDROCHLORIDE	5GM/PACKET	GRANULE;ORAL	Prescription	Yes	AB	017563	PFIZER
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	5GM/PACKET	GRANULE;ORAL	Prescription	No	AB	077277	IMPAX LABS