Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206887
Company: MACLEODS PHARMS LTD

Products on ANDA 206887

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206887

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2017	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
06/07/2023	SUPPL-16	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206887

IBANDRONATE SODIUM

TABLET;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	078948	APOTEX INC
IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	204502	AUROBINDO PHARMA
IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	078997	DR REDDYS LABS LTD
IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	206887	MACLEODS PHARMS LTD
IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	078998	ORBION PHARMS
IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	079003	WATSON LABS TEVA