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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204724
Company: GLENMARK PHARMS LTD

Products on ANDA 204724

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204724

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

Therapeutic Equivalents for ANDA 204724

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
SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	400MG	TABLET;ORAL	Prescription	No	AB	213145	LUPIN
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	204724	GLENMARK PHARMS LTD
SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	800MG	TABLET;ORAL	Prescription	No	AB	213145	LUPIN
SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	800MG	TABLET;ORAL	Prescription	No	AB	206883	MACLEODS PHARMS LTD
SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	800MG	TABLET;ORAL	Prescription	No	AB	218966	NAVINTA LLC

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