You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

Details for New Drug Application (NDA): 019264

✉ Email this page to a colleague

« Back to Dashboard

NDA 019264 describes PENTAM, which is a drug marketed by Fresenius Kabi Usa, Seton Pharms, X-gen Pharms Inc, Avet Lifesciences, Baxter Hlthcare, Hospira, Watson Labs, and Xgen Pharms, and is included in nine 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. Four 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

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.