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Last Updated: November 2, 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
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:RXDosage:FOR SOLUTION;INHALATIONStrength300MG/VIAL
Approval Date:Apr 24, 2019TE:ANRLD:No

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