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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077510
Company: IMPAX LABS

Products on ANDA 077510

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077510

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/24/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077510s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/15/2026	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
04/15/2026	SUPPL-28	Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/15/2026	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/09/2014	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 077510

COLESTIPOL HYDROCHLORIDE

TABLET;ORAL; 1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COLESTID	COLESTIPOL HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	Yes	AB	020222	PFIZER
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	216517	ANI PHARMS
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	217667	EDENBRIDGE PHARMS
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	077510	IMPAX LABS
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	220012	PHARMOBEDIENT
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	217462	RICONPHARMA LLC
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	215223	ZYDUS PHARMS

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