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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

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

Antifungal Agents
Antiprotozoal Agents
Trypanocidal Agents

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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	300MG/VIAL
Approval Date:	Oct 16, 1984	TE:	AP	RLD:	Yes

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