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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 206667

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NDA 206667 describes PENTAMIDINE ISETHIONATE, which is a drug marketed by Seton Pharms, X-gen Pharms Inc, Avet Lifesciences, Baxter Hlthcare, Hospira, Watson Labs, and Xgen Pharms, and is included in eight NDAs. It is available from three suppliers. Additional details are available on the PENTAMIDINE ISETHIONATE profile page.

The generic ingredient in PENTAMIDINE ISETHIONATE 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 206667

Tradename:	PENTAMIDINE ISETHIONATE
Applicant:	Seton Pharms
Ingredient:	pentamidine isethionate
Patents:	0

Pharmacology for NDA: 206667

Medical Subject Heading (MeSH) Categories for 206667

Antifungal Agents
Antiprotozoal Agents
Trypanocidal Agents

Suppliers and Packaging for NDA: 206667

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PENTAMIDINE ISETHIONATE	pentamidine isethionate	FOR SOLUTION;INHALATION	206667	ANDA	Seton Pharmaceuticals	13925-522	13925-522-01	1 VIAL in 1 CARTON (13925-522-01) / 300 mg in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;INHALATION			Strength	300MG/VIAL
Approval Date:	Apr 24, 2019	TE:	AN	RLD:	No

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