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Last Updated: June 10, 2023

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, Emcure Pharms Ltd, Hospira, Watson Labs, and Xgen Pharms, and is included in eight 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. Three suppliers are listed for this compound. Additional details are available on the pentamidine isethionate profile page.
Summary for 019264
Applicant:Fresenius Kabi Usa
Ingredient:pentamidine isethionate
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 (63323-113-01)

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

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