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Last Updated: April 13, 2024

Details for New Drug Application (NDA): 019887

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NDA 019887 describes NEBUPENT, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from one supplier. Additional details are available on the NEBUPENT profile page.

The generic ingredient in NEBUPENT is pentamidine isethionate. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the pentamidine isethionate profile page.
Summary for 019887
Applicant:Fresenius Kabi Usa
Ingredient:pentamidine isethionate
Formulation / Manufacturing:see details
Pharmacology for NDA: 019887
Medical Subject Heading (MeSH) Categories for 019887
Suppliers and Packaging for NDA: 019887
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEBUPENT pentamidine isethionate FOR SOLUTION;INHALATION 019887 NDA Fresenius Kabi USA, LLC 63323-877 63323-877-15 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-877-15) / 6 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;INHALATIONStrength300MG/VIAL
Approval Date:Jun 15, 1989TE:ANRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;INHALATIONStrength600MG/VIAL
Approval Date:Mar 22, 1996TE:RLD:No

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