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Details for New Drug Application (NDA): 021883

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NDA 021883 describes DALVANCE, which is a drug marketed by Durata Theraps Intl and is included in one NDA. It is available from one supplier. There are four patents 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 NDA: 021883

Tradename:
DALVANCE
Applicant:
Durata Theraps Intl
Ingredient:
dalbavancin hydrochloride
Patents:4

Pharmacology for NDA: 021883

Ingredient-typeLipoglycopeptides

Suppliers and Packaging for NDA: 021883

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DALVANCE
dalbavancin hydrochloride
POWDER;IV (INFUSION) 021883 NDA Durata Therapeutics Inc. 57970-100 57970-100-01 1 VIAL in 1 PACKAGE (57970-100-01) > 25 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)StrengthEQ 500MG BASE/VIAL
Approval Date:May 23, 2014TE:RLD:Yes
Patent:7,115,564Patent Expiration:Nov 14, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:7,119,061Patent Expiration:Nov 14, 2023Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Jan 20, 2019
Regulatory Exclusivity Use:ADDITION OF A 1500MG-SINGLE-DOSE REGIMEN FOR THE TREATMENT OF ADULT PATIENTS WITH ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSI)


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