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Drugs@FDA: FDA-Approved Drugs

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

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 INC
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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