Details for New Drug Application (NDA): 021883

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NDA 021883 describes DALVANCE, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the DALVANCE profile page.

The generic ingredient in DALVANCE is dalbavancin hydrochloride. One supplier is listed for this compound. Additional details are available on the dalbavancin hydrochloride profile page.

Summary for 021883

Tradename:	DALVANCE
Applicant:	Abbvie
Ingredient:	dalbavancin hydrochloride
Patents:	1

Pharmacology for NDA: 021883

Suppliers and Packaging for NDA: 021883

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883	NDA	Allergan, Inc.	57970-100	57970-100-01	1 VIAL in 1 PACKAGE (57970-100-01) / 25 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 500MG BASE/VIAL
Approval Date:	May 23, 2014	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 23, 2024
Regulatory Exclusivity Use:	GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:	May 23, 2019
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	Jul 22, 2024
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Expired US Patents for NDA 021883

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014	⤷ Sign Up	⤷ Sign Up
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014	⤷ Sign Up	⤷ Sign Up
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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