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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 213806

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NDA 213806 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 213806

Tradename:	PENTAMIDINE ISETHIONATE
Applicant:	Avet Lifesciences
Ingredient:	pentamidine isethionate
Patents:	0

Pharmacology for NDA: 213806

Medical Subject Heading (MeSH) Categories for 213806

Antifungal Agents
Antiprotozoal Agents
Trypanocidal Agents

Suppliers and Packaging for NDA: 213806

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PENTAMIDINE ISETHIONATE	pentamidine isethionate	INJECTABLE;INJECTION	213806	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-748	23155-748-41	10 VIAL, SINGLE-DOSE in 1 CARTON (23155-748-41) / 300 mg in 1 VIAL, SINGLE-DOSE (23155-748-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	300MG/VIAL
Approval Date:	Jan 7, 2021	TE:	AP	RLD:	No

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