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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219984
Company: GLAND

Products on ANDA 219984

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219984

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/05/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219984

ZOLEDRONIC ACID

INJECTABLE;INTRAVENOUS; EQ 4MG BASE/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ZOLEDRONIC	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	205749	GLAND
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	210174	AMNEAL
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	219984	GLAND
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	203231	INFORLIFE

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