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Generated: June 18, 2019

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Details for New Drug Application (NDA): 065197

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NDA 065197 describes CEFOTAXIME SODIUM, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cephazone Pharma, Hospira Inc, Lupin, and Wockhardt, and is included in nine NDAs. It is available from three suppliers. Additional details are available on the CEFOTAXIME SODIUM profile page.

The generic ingredient in CEFOTAXIME SODIUM 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 065197
Tradename:CEFOTAXIME SODIUM
Applicant:Wockhardt
Ingredient:cefotaxime sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065197
Medical Subject Heading (MeSH) Categories for 065197
Suppliers and Packaging for NDA: 065197
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFOTAXIME cefotaxime sodium INJECTABLE;INJECTION 065197 ANDA WOCKHARDT LIMITED 55648-947 55648-947-02 10 CARTON in 1 CARTON (55648-947-02) > 1 VIAL, SINGLE-DOSE in 1 CARTON (55648-947-01) > 10 mL in 1 VIAL, SINGLE-DOSE
CEFOTAXIME cefotaxime sodium INJECTABLE;INJECTION 065197 ANDA WOCKHARDT LIMITED 55648-948 55648-948-02 10 CARTON in 1 CARTON (55648-948-02) > 1 VIAL, SINGLE-DOSE in 1 CARTON (55648-948-01) > 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Aug 29, 2006TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 20, 2008TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Jun 20, 2008TE:APRLD:No

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