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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206100
Company: MACLEODS PHARMS LTD

Products on ANDA 206100

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206100

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/10/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206100

SEVELAMER CARBONATE

TABLET;ORAL; 800MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RENVELA	SEVELAMER CARBONATE	800MG	TABLET;ORAL	Prescription	Yes	AB	022127	SANOFI
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET;ORAL	Prescription	No	AB	207288	AMNEAL PHARMS CO
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET;ORAL	Prescription	No	AB	212970	ANXIN
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET;ORAL	Prescription	No	AB	200959	ARTHUR GRP
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET;ORAL	Prescription	No	AB	207179	AUROBINDO PHARMA
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET;ORAL	Prescription	No	AB	206094	DR REDDYS
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET;ORAL	Prescription	No	AB	203860	INVAGEN PHARMS
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET;ORAL	Prescription	No	AB	206100	MACLEODS PHARMS LTD
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET;ORAL	Prescription	No	AB	215537	MICRO LABS
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET;ORAL	Prescription	No	AB	204451	RISING
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET;ORAL	Prescription	No	AB	207759	ZYDUS PHARMS

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