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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019264

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NDA 019264 describes PENTAM, which is a drug marketed by Fresenius Kabi Usa, Seton Pharms, Baxter Hlthcare, Hospira, and Watson Labs, and is included in six NDAs. It is available from one supplier. Additional details are available on the PENTAM profile page.

The generic ingredient in PENTAM is pentamidine isethionate. There are fourteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pentamidine isethionate profile page.
Summary for 019264
Tradename:PENTAM
Applicant:Fresenius Kabi Usa
Ingredient:pentamidine isethionate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019264
Medical Subject Heading (MeSH) Categories for 019264
Suppliers and Packaging for NDA: 019264
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENTAM pentamidine isethionate INJECTABLE;INJECTION 019264 NDA Fresenius Kabi USA, LLC 63323-113 63323-113-10 10 VIAL in 1 TRAY (63323-113-10) > 3 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength300MG/VIAL
Approval Date:Oct 16, 1984TE:APRLD:Yes

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