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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078998
Company: ORBION PHARMS

Products on ANDA 078998

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 078998

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			Review (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/078998Orig1s000OtherActionLtrs.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/078998Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2023	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/15/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
07/15/2015	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078998

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

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