Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210464
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION;ORAL Prescription AB No No
SEVELAMER CARBONATE SEVELAMER CARBONATE 2.4GM/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
10/25/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

SEVELAMER CARBONATE

FOR SUSPENSION;ORAL; 800MG/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RENVELA SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION;ORAL Prescription Yes AB 022318 GENZYME
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION;ORAL Prescription No AB 207624 AUROBINDO PHARMA LTD
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION;ORAL Prescription No AB 210464 DR REDDYS LABS LTD

FOR SUSPENSION;ORAL; 2.4GM/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RENVELA SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION;ORAL Prescription Yes AB 022318 GENZYME
SEVELAMER CARBONATE SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 207624 AUROBINDO PHARMA LTD
SEVELAMER CARBONATE SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 210464 DR REDDYS LABS LTD

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