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Last Updated: November 4, 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
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:RXDosage:INJECTABLE;INJECTIONStrength300MG/VIAL
Approval Date:Jan 7, 2021TE:APRLD:No

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