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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205254
Company: MYLAN LABS LTD

Products on ANDA 205254

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205254

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/27/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/07/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205254

ZOLEDRONIC ACID

INJECTABLE;INTRAVENOUS; EQ 5MG BASE/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RECLAST	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	021817	SANDOZ
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	200918	AKORN
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204367	APOTEX
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	091363	DR REDDYS LABS LTD
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204217	GLAND
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	209578	GLAND PHARMA LTD
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202837	HOSPIRA INC
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202828	INFORLIFE
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	213371	MEITHEAL
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203841	MYLAN LABS LTD
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	205254	MYLAN LABS LTD
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202163	PII

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