Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204222
Company: APOTEX

Products on ANDA 204222

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE;INTRAVENOUS	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204222

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2015	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
12/17/2019	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 204222

IBANDRONATE SODIUM

INJECTABLE;INTRAVENOUS; EQ 3MG BASE/3ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	206058	ACCORD HLTHCARE
IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204222	APOTEX
IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	205332	EUGIA PHARMA
IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202671	MYLAN LABS LTD
IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202235	SAGENT PHARMS INC
IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	090853	SUN PHARM