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Generated: November 21, 2018

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Details for New Drug Application (NDA): 065071

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NDA 065071 describes CEFOTAXIME, which is a drug marketed by Fresenius Kabi Usa, Hikma, Wockhardt, B Braun, Aurobindo Pharma, Aurobindo Pharma Ltd, Cephazone Pharma, Hospira Inc, and Lupin, and is included in fourteen NDAs. It is available from four suppliers. Additional details are available on the CEFOTAXIME profile page.

The generic ingredient in CEFOTAXIME is cefotaxime sodium. There are fourteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the cefotaxime sodium profile page.
Summary for 065071
Ingredient:cefotaxime sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 065071
Medical Subject Heading (MeSH) Categories for 065071
Suppliers and Packaging for NDA: 065071
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFOTAXIME cefotaxime sodium INJECTABLE;INJECTION 065071 ANDA West-Ward Pharmaceutical Corp 0143-9935 0143-9935-01 1 INJECTION in 1 PACKAGE (0143-9935-01)

Profile for product number 001

Approval Date:Nov 20, 2002TE:APRLD:No

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