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Details for New Drug Application (NDA): 019264

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NDA 019264 describes PENTAM, which is a drug marketed by Fresenius Kabi Usa, Watson Labs, Baxter Hlthcare, and Hospira, and is included in four NDAs. It is available from one supplier. Additional details are available on the PENTAM profile page.

The generic ingredient in PENTAM is pentamidine isethionate. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pentamidine isethionate profile page.

Summary for NDA: 019264

Fresenius Kabi Usa
pentamidine isethionate
Therapeutic Class:Antiparasitics

Pharmacology for NDA: 019264

Suppliers and Packaging for NDA: 019264

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
pentamidine isethionate
INJECTABLE;INJECTION 019264 NDA APP Pharmaceuticals, LLC 63323-113 63323-113-10 10 VIAL in 1 TRAY (63323-113-10) > 3 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength300MG/VIAL
Approval Date:Oct 16, 1984TE:RLD:Yes

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.