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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203533
Company: MACLEODS PHARMS LTD

Products on ANDA 203533

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RISEDRONATE SODIUM	RISEDRONATE SODIUM	5MG	TABLET;ORAL	Prescription	AB	No	No
RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET;ORAL	Prescription	AB	No	No
RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203533

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2016	ORIG-2	Approval				Label is not available on this site.
12/09/2015	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/23/2024	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/07/2023	SUPPL-20	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
05/23/2024	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/23/2024	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 203533

RISEDRONATE SODIUM

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RISEDRONATE SODIUM	RISEDRONATE SODIUM	5MG	TABLET;ORAL	Prescription	No	AB	200296	AUROBINDO PHARMA LTD
RISEDRONATE SODIUM	RISEDRONATE SODIUM	5MG	TABLET;ORAL	Prescription	No	AB	203533	MACLEODS PHARMS LTD
RISEDRONATE SODIUM	RISEDRONATE SODIUM	5MG	TABLET;ORAL	Prescription	No	AB	090886	SUN PHARM
RISEDRONATE SODIUM	RISEDRONATE SODIUM	5MG	TABLET;ORAL	Prescription	No	AB	077132	TEVA PHARMS USA

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET;ORAL	Prescription	No	AB	200296	AUROBINDO PHARMA LTD
RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET;ORAL	Prescription	No	AB	203533	MACLEODS PHARMS LTD
RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET;ORAL	Prescription	No	AB	205280	ORBION PHARMS
RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET;ORAL	Prescription	No	AB	090886	SUN PHARM
RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET;ORAL	Prescription	No	AB	077132	TEVA PHARMS USA

TABLET;ORAL; 35MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACTONEL	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	Yes	AB	020835	APIL
RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	No	AB	090877	APOTEX
RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	No	AB	200296	AUROBINDO PHARMA LTD
RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	No	AB	203533	MACLEODS PHARMS LTD
RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	No	AB	205280	ORBION PHARMS
RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	No	AB	090886	SUN PHARM
RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	No	AB	077132	TEVA PHARMS USA

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