Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207624
Company: AUROBINDO PHARMA 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
06/13/2017 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207624Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207624Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/25/2020 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/13/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207624Orig1s000lbl.pdf

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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