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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090853
Company: SUN PHARM

Products on ANDA 090853

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 090853

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/14/2014	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/090853Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090853Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/02/2015	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Labels for ANDA 090853

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/14/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/090853Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 090853

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

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