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Generated: November 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065374

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NDA 065374 describes CEFOTETAN, which is a drug marketed by Fresenius Kabi Usa, Hikma Farmaceutica, West-ward Pharm Corp, and B Braun, and is included in five NDAs. It is available from two suppliers. Additional details are available on the CEFOTETAN profile page.

The generic ingredient in CEFOTETAN is cefotetan disodium. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cefotetan disodium profile page.
Summary for 065374
Tradename:CEFOTETAN
Applicant:Fresenius Kabi Usa
Ingredient:cefotetan disodium
Patents:0
Pharmacology for NDA: 065374
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 065374
Suppliers and Packaging for NDA: 065374
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFOTETAN cefotetan disodium INJECTABLE;INJECTION 065374 ANDA Fresenius Kabi USA, LLC 63323-385 63323-385-10 10 VIAL in 1 CARTON (63323-385-10) > 10 mL in 1 VIAL
CEFOTETAN cefotetan disodium INJECTABLE;INJECTION 065374 ANDA Fresenius Kabi USA, LLC 63323-386 63323-386-20 10 VIAL in 1 CARTON (63323-386-20) > 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Aug 9, 2007TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Aug 9, 2007TE:APRLD:No

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