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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065204

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NDA 065204 describes CEFTRIAXONE, which is a drug marketed by Acs Dobfar, Agila Speclts, Aurobindo Pharma Ltd, Bedford, Facta Farma, Fresenius Kabi Usa, Hospira Inc, Lupin, Samson Medcl, Sandoz, Sandoz Inc, Teva, Wockhardt, Akorn Inc, Cephazone Pharma, Hikma Farmaceutica, Qilu Pharm Co Ltd, Teva Pharms Usa, B Braun, Baxter Hlthcare, and Sagent Pharms, and is included in thirty-four NDAs. It is available from twenty-seven suppliers. Additional details are available on the CEFTRIAXONE profile page.

The generic ingredient in CEFTRIAXONE is ceftriaxone sodium. There are twenty-four drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
Summary for 065204
Tradename:CEFTRIAXONE
Applicant:Sandoz Inc
Ingredient:ceftriaxone sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065204
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 065204
Suppliers and Packaging for NDA: 065204
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INJECTION 065204 ANDA Hospira, Inc 0409-7333 0409-7333-04 10 VIAL, SINGLE-USE in 1 CARTON (0409-7333-04) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INJECTION 065204 ANDA Hospira, Inc 0409-7333 0409-7333-49 10 VIAL, SINGLE-USE in 1 CARTON (0409-7333-49) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:May 3, 2005TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:May 3, 2005TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

US Army
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Novartis
Harvard Business School
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Boehringer Ingelheim
Citi
Queensland Health

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