An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
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
IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	079003	WATSON LABS TEVA

Top