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Generated: November 14, 2018

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Details for New Drug Application (NDA): 208611

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NDA 208611 describes BAXDELA, which is a drug marketed by Melinta and is included in two NDAs. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the BAXDELA profile page.

The generic ingredient in BAXDELA is delafloxacin meglumine. One supplier is listed for this compound. Additional details are available on the delafloxacin meglumine profile page.
Summary for 208611
Tradename:BAXDELA
Applicant:Melinta
Ingredient:delafloxacin meglumine
Patents:12
Generic Entry Opportunity Date for 208611
Generic Entry Date for 208611*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;IV (INFUSION)

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 208611
Ingredient-typeFluoroquinolones
Suppliers and Packaging for NDA: 208611
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BAXDELA delafloxacin meglumine POWDER;INTRAVENOUS 208611 NDA Melinta Therapeutics, Inc 70842-102 70842-102-03 1 VIAL, GLASS in 1 CARTON (70842-102-03) > 10.5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 300MG BASE/VIAL
Approval Date:Jun 19, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 19, 2027
Regulatory Exclusivity Use:GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:Jun 19, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?

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