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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207624
Company: AUROBINDO PHARMA

Products on ANDA 207624

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 207624

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2017	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207624Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207624Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2022	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
03/25/2020	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Labels for ANDA 207624

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/13/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207624Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 207624

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 INC
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

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	210464	DR REDDYS
SEVELAMER CARBONATE	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	211316	IMPAX

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