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Serving leading biopharmaceutical companies globally:

Healthtrust
Queensland Health
Teva
US Army
Colorcon
Federal Trade Commission
Mallinckrodt
Boehringer Ingelheim
Farmers Insurance
AstraZeneca

Generated: December 17, 2017

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, Baxter Hlthcare, Hospira, Seton Pharms, and Watson Labs, and is included in five 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 thirteen 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

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antiparasitics
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 APP Pharmaceuticals, LLC 63323-113 63323-113-10 10 VIAL in 1 TRAY (63323-113-10) > 3 mL in 1 VIAL

Summary 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:

Fuji
Cerilliant
Chinese Patent Office
Healthtrust
QuintilesIMS
Johnson and Johnson
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Citi
Merck
Chubb

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