o, IL 60606
US Patent Numbers: Available online at http://www.duratatherapeutics.com/products/product-patents
DALVANCETM is a trademark of Durata Therapeutics Holding C.V
Close
PRINCIPAL DISPLAY PANEL
Principal Display Panel
NDC 57970-100-01
Dalvance
(dalbavancin) for injection
500 mg per vial
For Intravenous Infusion Only
Sterile Single Dose Vial
Close
INGREDIENTS AND APPEARANCE
DALVANCE
dalbavancin injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57970-100
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DALBAVANCIN HYDROCHLORIDE (UNII: 33WDQ7T81E) (DALBAVANCIN - UNII:808UI9MS5K) DALBAVANCIN 500 mg in 25 mL
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) 129 mg in 25 mL
MANNITOL (UNII: 3OWL53L36A) 129 mg in 25 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57970-100-01 1 in 1 PACKAGE
1 25 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021883 05/23/2014
Labeler - Durata Therapeutics Inc. (078520687)
Establishment
Name Address ID/FEI Business Operations
Associates of Cape Cod, Inc 076574078 ANALYSIS(57970-100)
Establishment
Name Address ID/FEI Business Operations
Gnosis Bioresearch Srl 438597283 ANALYSIS(57970-100) , API MANUFACTURE(57970-100)
Establishment
Name Address ID/FEI Business Operations
Hospira, Inc. 030606222 ANALYSIS(57970-100) , LABEL(57970-100) , MANUFACTURE(57970-100) , PACK(57970-100)
|
