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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219465
Company: TEVA PHARMS INC

Products on ANDA 219465

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DALBAVANCIN HYDROCHLORIDE	DALBAVANCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219465

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/23/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219465

DALBAVANCIN HYDROCHLORIDE

POWDER;INTRAVENOUS; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DALBAVANCIN HYDROCHLORIDE	DALBAVANCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	217591	FRESENIUS KABI USA
DALBAVANCIN HYDROCHLORIDE	DALBAVANCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	218929	KINDOS
DALBAVANCIN HYDROCHLORIDE	DALBAVANCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	219465	TEVA PHARMS INC
DALVANCE	DALBAVANCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	021883	ABBVIE

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