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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 206983

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NDA 206983 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 206983

Tradename:	PENTAMIDINE ISETHIONATE
Applicant:	X-gen Pharms Inc
Ingredient:	pentamidine isethionate
Patents:	0

Pharmacology for NDA: 206983

Medical Subject Heading (MeSH) Categories for 206983

Antifungal Agents
Antiprotozoal Agents
Trypanocidal Agents

Suppliers and Packaging for NDA: 206983

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PENTAMIDINE ISETHIONATE	pentamidine isethionate	FOR SOLUTION;INHALATION	206983	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-3030	39822-3030-2	1 VIAL, SINGLE-DOSE in 1 CARTON (39822-3030-2) / 6 mL in 1 VIAL, SINGLE-DOSE (39822-3030-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;INHALATION			Strength	300MG/VIAL
Approval Date:	Jan 20, 2023	TE:	AN	RLD:	No

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