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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 212862


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NDA 212862 describes PRETOMANID, which is a drug marketed by Mylan Ireland Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the PRETOMANID profile page.

The generic ingredient in PRETOMANID is pretomanid. One supplier is listed for this compound. Additional details are available on the pretomanid profile page.
Summary for 212862
Tradename:PRETOMANID
Applicant:Mylan Ireland Ltd
Ingredient:pretomanid
Patents:0
Pharmacology for NDA: 212862
Suppliers and Packaging for NDA: 212862
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRETOMANID pretomanid TABLET;ORAL 212862 NDA Mylan Specialty L.P. 49502-476 49502-476-26 1 BOTTLE in 1 CARTON (49502-476-26) / 26 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Aug 14, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 14, 2029
Regulatory Exclusivity Use:GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:Aug 14, 2026
Regulatory Exclusivity Use:INDICATED AS PART OF A COMBINATION REGIMEN WITH BEDAQUILINE AND LINEZOLID FOR THE TREATMENT OF ADULTS WITH PULMONARY EXTENSIVELY DRUG RESISTANT (XDR) OR TREATMENT-INTOLERANT OR NONRESPONSIVE MULTIDRUG-RESISTANT (MDR) TUBERCULOSIS (TB)
Regulatory Exclusivity Expiration:Aug 14, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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