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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 206982


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NDA 206982 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 206982
Tradename:PENTAMIDINE ISETHIONATE
Applicant:Xgen Pharms
Ingredient:pentamidine isethionate
Patents:0
Pharmacology for NDA: 206982
Medical Subject Heading (MeSH) Categories for 206982
Suppliers and Packaging for NDA: 206982
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENTAMIDINE ISETHIONATE pentamidine isethionate INJECTABLE;INJECTION 206982 ANDA XGen Pharmaceuticals DJB, Inc. 39822-3050 39822-3050-2 10 VIAL in 1 CARTON (39822-3050-2) / 3 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength300MG/VIAL
Approval Date:Mar 17, 2022TE:APRLD:No

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