Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202190
Company: GLENMARK PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE 1.875GM/PACKET FOR SUSPENSION;ORAL Prescription None No No
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
07/16/2018 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202190Orig1s000ltr.pdf

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 DAIICHI SANKYO

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