Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 9, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065415

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NDA 065415 describes CEFOXITIN, which is a drug marketed by Acs Dobfar, Acs Dobfar Spa, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira Inc, West-ward Pharms Int, B Braun, and Samson Medcl, and is included in fourteen NDAs. It is available from four suppliers. Additional details are available on the CEFOXITIN profile page.

The generic ingredient in CEFOXITIN is cefoxitin sodium. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cefoxitin sodium profile page.
Summary for 065415
Tradename:CEFOXITIN
Applicant:Acs Dobfar
Ingredient:cefoxitin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065415
Medical Subject Heading (MeSH) Categories for 065415
Suppliers and Packaging for NDA: 065415
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFOXITIN cefoxitin sodium INJECTABLE;INJECTION 065415 ANDA Sagent Pharmaceuticals 25021-111 25021-111-99 10 BOTTLE in 1 CARTON (25021-111-99) > 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
CEFOXITIN cefoxitin sodium INJECTABLE;INJECTION 065415 ANDA WG Critical Care, LLC 44567-247 44567-247-10 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (44567-247-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL
Approval Date:May 19, 2010TE:APRLD:No

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