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Generated: January 22, 2019

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Details for New Drug Application (NDA): 065375

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NDA 065375 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 065375
Applicant:Fresenius Kabi Usa
Ingredient:cefotetan disodium
Pharmacology for NDA: 065375
Medical Subject Heading (MeSH) Categories for 065375
Suppliers and Packaging for NDA: 065375
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFOTETAN cefotetan disodium INJECTABLE;INJECTION 065375 ANDA Fresenius Kabi USA, LLC 63323-396 63323-396-61 1 VIAL in 1 BOX (63323-396-61) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Profile for product number 001

Approval Date:Aug 9, 2007TE:APRLD:No

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