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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210316
Company: ALKEM LABS LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET FOR SUSPENSION;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
05/06/2019 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/16/2020 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

COLESEVELAM HYDROCHLORIDE

FOR SUSPENSION;ORAL; 3.75GM/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 210316 ALKEM LABS LTD
COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 202190 GLENMARK PHARMS LTD
WELCHOL COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET FOR SUSPENSION;ORAL Prescription Yes AB 022362 COSETTE
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