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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 206334


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NDA 206334 describes ORBACTIV, which is a drug marketed by Melinta Therap 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 206334
Tradename:ORBACTIV
Applicant:Melinta Therap
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;INTRAVENOUS 206334 NDA Melinta Therapeutics, LLC 70842-140 70842-140-03 3 VIAL, GLASS in 1 CARTON (70842-140-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70842-140-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 400MG BASE/VIAL
Approval Date:Aug 6, 2014TE:RLD:Yes
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
Patent:⤷  SubscribePatent Expiration:Aug 29, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS USING A SINGLE DOSE

Expired US Patents for NDA 206334

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Melinta Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014 ⤷  Subscribe ⤷  Subscribe
Melinta Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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