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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202182
Company: HIKMA FARMACEUTICA

Products on ANDA 202182

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202182

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/03/2013	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/20/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/20/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
10/20/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
11/19/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202182

ZOLEDRONIC ACID

INJECTABLE;INTRAVENOUS; EQ 4MG BASE/5ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	205279	ACCORD HLTHCARE
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	201783	AVET LIFESCIENCES
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207341	BPI LABS
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202571	CHARTWELL RX
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	091186	DR REDDYS LABS LTD
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202548	EPIC PHARMA LLC
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	091516	FRESENIUS KABI USA
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202930	GLAND PHARMA LTD
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202182	HIKMA FARMACEUTICA
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	090621	HOSPIRA
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202650	MYLAN LABS LTD
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	091493	SAGENT PHARMS INC
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202923	USV

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