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Abbreviated New Drug Application (ANDA): 207179
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG TABLET;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
07/17/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207179Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/18/2020 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/18/2020 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

SEVELAMER CARBONATE

TABLET;ORAL; 800MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RENVELA SEVELAMER CARBONATE 800MG TABLET;ORAL Prescription Yes AB 022127 SANOFI
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG TABLET;ORAL Prescription No AB 207288 AMNEAL PHARMS CO
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG TABLET;ORAL Prescription No AB 212970 ANXIN
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG TABLET;ORAL Prescription No AB 200959 ARTHUR GRP
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG TABLET;ORAL Prescription No AB 207179 AUROBINDO PHARMA
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG TABLET;ORAL Prescription No AB 206094 DR REDDYS
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG TABLET;ORAL Prescription No AB 203860 INVAGEN PHARMS
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG TABLET;ORAL Prescription No AB 215537 MICRO LABS
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG TABLET;ORAL Prescription No AB 204451 RISING
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG TABLET;ORAL Prescription No AB 207759 ZYDUS PHARMS
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