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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 063239

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NDA 063239 describes ROCEPHIN, which is a drug marketed by Roche and Hoffmann La Roche and is included in five NDAs. Additional details are available on the ROCEPHIN profile page.

The generic ingredient in ROCEPHIN is ceftriaxone sodium; lidocaine. There are twenty-three drug master file entries for this compound. Additional details are available on the ceftriaxone sodium; lidocaine profile page.

Summary for NDA: 063239

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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL
Approval Date:Aug 13, 1993TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Aug 13, 1993TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Aug 13, 1993TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Medtronic
UBS
Baxter
Teva
Moodys
Chubb
Healthtrust
Express Scripts
Covington
Chinese Patent Office

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