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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213145
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 400MG TABLET;ORAL Prescription AB No No
SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 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
06/16/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

SEVELAMER HYDROCHLORIDE

TABLET;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RENAGEL SEVELAMER HYDROCHLORIDE 400MG TABLET;ORAL Prescription Yes AB 021179 GENZYME
SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 400MG TABLET;ORAL Prescription No AB 212599 AUROBINDO PHARMA LTD
SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 400MG TABLET;ORAL Prescription No AB 204724 GLENMARK PHARMS LTD
SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 400MG TABLET;ORAL Prescription No AB 213145 LUPIN LTD
SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 400MG TABLET;ORAL Prescription No AB 206883 MACLEODS PHARMS LTD

TABLET;ORAL; 800MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RENAGEL SEVELAMER HYDROCHLORIDE 800MG TABLET;ORAL Prescription Yes AB 021179 GENZYME
SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 800MG TABLET;ORAL Prescription No AB 212599 AUROBINDO PHARMA LTD
SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 800MG TABLET;ORAL Prescription No AB 204724 GLENMARK PHARMS LTD
SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 800MG TABLET;ORAL Prescription No AB 213145 LUPIN LTD
SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 800MG TABLET;ORAL Prescription No AB 206883 MACLEODS PHARMS LTD
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