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Details for New Drug Application (NDA): 206334

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NDA 206334 describes ORBACTIV, which is a drug marketed by The Medicines Co and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ORBACTIV profile page.

The generic ingredient in ORBACTIV is oritavancin diphosphate. One supplier is listed for this compound. Additional details are available on the oritavancin diphosphate profile page.

Summary for NDA: 206334

Tradename:
ORBACTIV
Applicant:
The Medicines Co
Ingredient:
oritavancin diphosphate
Patents:3

Suppliers and Packaging for NDA: 206334

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORBACTIV
oritavancin diphosphate
POWDER;IV (INFUSION) 206334 NDA The Medicines Company 65293-015 65293-015-03 3 VIAL, GLASS in 1 CARTON (65293-015-03) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (65293-015-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)StrengthEQ 400MG BASE/VIAL
Approval Date:Aug 6, 2014TE:RLD:Yes
Patent:5,998,581Patent Expiration:Nov 12, 2017Product Flag?Substance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Aug 6, 2024
Regulatory Exclusivity Use:GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:Aug 6, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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