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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078948
Company: APOTEX INC

Products on ANDA 078948

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 078948

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/19/2012	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
02/03/2026	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/27/2023	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/23/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/24/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
07/24/2015	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/24/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078948

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

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