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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211316
Company: IMPAX

Products on ANDA 211316

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION;ORAL	Prescription	AB	No	No
SEVELAMER CARBONATE	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211316

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211316

SEVELAMER CARBONATE

FOR SUSPENSION;ORAL; 800MG/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RENVELA	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION;ORAL	Prescription	Yes	AB	022318	GENZYME
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	207624	AUROBINDO PHARMA
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	209374	BIONPHARMA
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	217319	CHARTWELL RX
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	210464	DR REDDYS
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	211316	IMPAX
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	207291	MACLEODS PHARMS LTD
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	211917	STRIDES PHARMA INTL

FOR SUSPENSION;ORAL; 2.4GM/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RENVELA	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION;ORAL	Prescription	Yes	AB	022318	GENZYME
SEVELAMER CARBONATE	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	207624	AUROBINDO PHARMA
SEVELAMER CARBONATE	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	217319	CHARTWELL RX
SEVELAMER CARBONATE	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	210464	DR REDDYS
SEVELAMER CARBONATE	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	211316	IMPAX
SEVELAMER CARBONATE	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	207291	MACLEODS PHARMS LTD
SEVELAMER CARBONATE	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	211917	STRIDES PHARMA INTL

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