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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209038
Company: ALKEM LABS LTD

Products on ANDA 209038

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209038

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/05/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209038

COLESEVELAM HYDROCHLORIDE

TABLET;ORAL; 625MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET;ORAL	Prescription	No	AB	209038	ALKEM LABS LTD
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET;ORAL	Prescription	No	AB	206036	BEIJING TIDE PHARM
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET;ORAL	Prescription	No	AB	208670	BIONPHARMA
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET;ORAL	Prescription	No	AB	210889	DR REDDYS
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET;ORAL	Prescription	No	AB	203480	GLENMARK PHARMS LTD
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET;ORAL	Prescription	No	AB	091600	IMPAX LABS INC
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET;ORAL	Prescription	No	AB	212050	INVENTIA
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET;ORAL	Prescription	No	AB	213456	SPH
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET;ORAL	Prescription	No	AB	209946	ZHEJIANG JINGXIN
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET;ORAL	Prescription	No	AB	207765	ZYDUS PHARMS
WELCHOL	COLESEVELAM HYDROCHLORIDE	625MG	TABLET;ORAL	Prescription	Yes	AB	021176	COSETTE

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