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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212599
Company: AUROBINDO PHARMA LTD

Products on ANDA 212599

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 212599

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/11/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212599

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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