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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209374
Company: BIONPHARMA

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/17/2021 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
01/07/2022 SUPPL-1 Labeling-Container/Carton Labels

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
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION;ORAL Prescription No AB 209374 BIONPHARMA
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION;ORAL Prescription No AB 217319 CHARTWELL RX
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION;ORAL Prescription No AB 210464 DR REDDYS
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION;ORAL Prescription No AB 211316 IMPAX
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION;ORAL Prescription No AB 207291 MACLEODS PHARMS LTD
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION;ORAL Prescription No AB 211917 STRIDES PHARMA
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