Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 205332
Company: EUGIA PHARMA

Products on ANDA 205332

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205332

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/19/2015	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205332Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/31/2020	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 205332

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