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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091600
Company: IMPAX LABS INC

Products on ANDA 091600

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 091600

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/16/2018	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/091600Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/11/2024	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
10/11/2024	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/11/2024	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
10/11/2024	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091600

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	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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