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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065072

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NDA 065072 describes CEFOTAXIME, which is a drug marketed by Fresenius Kabi Usa, Hikma, Wockhardt, B Braun, Aurobindo Pharma Ltd, Aurobindo Pharma, Lupin, Hospira Inc, and Cephazone Pharma, and is included in fourteen NDAs. It is available from three 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. Four suppliers are listed for this compound. Additional details are available on the cefotaxime sodium profile page.

Summary for NDA: 065072

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 065072

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 065072

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFOTAXIME
cefotaxime sodium
INJECTABLE;INJECTION 065072 ANDA West-Ward Pharmaceutical Corp 0143-9930 0143-9930-10 10 VIAL in 1 PACKAGE (0143-9930-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9930-01)
CEFOTAXIME
cefotaxime sodium
INJECTABLE;INJECTION 065072 ANDA West-Ward Pharmaceutical Corp 0143-9931 0143-9931-25 25 VIAL in 1 PACKAGE (0143-9931-25) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9931-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Nov 20, 2002TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Nov 20, 2002TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Nov 20, 2002TE:APRLD:No


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