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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065329

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NDA 065329 describes CEFTRIAXONE, which is a drug marketed by Qilu Pharm Co Ltd, Aurobindo Pharma Ltd, Sandoz Inc, Akorn Inc, Lupin, Teva Pharms Usa, Acs Dobfar, Hospira Inc, Hikma Farmaceutica, Fresenius Kabi Usa, Samson Medcl, Teva, Bedford, Agila Speclts, Sandoz, Facta Farma, Wockhardt, Cephazone Pharma, B Braun, Baxter Hlthcare, and Sagent Pharms, and is included in thirty-three NDAs. It is available from twenty-four suppliers. Additional details are available on the CEFTRIAXONE profile page.

The generic ingredient in CEFTRIAXONE is ceftriaxone sodium. There are twenty-three drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.

Summary for NDA: 065329

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065329

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 065329

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFTRIAXONE
ceftriaxone sodium
 INJECTABLE;INJECTION 065329 ANDA Sagent Pharmaceuticals 25021-105 25021-105-10 25 VIAL in 1 CARTON (25021-105-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
CEFTRIAXONE
ceftriaxone sodium
 INJECTABLE;INJECTION 065329 ANDA Sagent Pharmaceuticals 25021-105 25021-105-66 25 VIAL in 1 CARTON (25021-105-66) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jul 24, 2008TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Jul 24, 2008TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Jul 24, 2008TE:APRLD:No


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US Department of Justice
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