Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204724
Company: GLENMARK PHARMS 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
02/08/2019 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204724Orig1s000ltr.pdf

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 204724 GLENMARK 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 204724 GLENMARK PHARMS LTD

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