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Serving leading biopharmaceutical companies globally:

Accenture
Harvard Business School
Cipla
Fish and Richardson
Farmers Insurance
Deloitte
Johnson and Johnson
Chinese Patent Office
Medtronic
AstraZeneca

Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078062

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NDA 078062 describes CIPROFLOXACIN, which is a drug marketed by Hikma Farmaceutica, Hospira, Baxter Hlthcare Corp, Lupin Ltd, Teva Pharms Usa, Fresenius Kabi Usa, Bedford Labs, Dr Reddys Labs Ltd, Actavis Labs Fl Inc, Sandoz, Anchen Pharms, Mylan Pharms Inc, Taro Pharm, Mylan, Barr, Carlsbad, Pliva, Apotex Inc, Teva, Nostrum Labs, Idt Australia Ltd, Unique Pharm Labs, Sun Pharm Inds Ltd, Teligent, Akorn Inc, Hikma, Aurobindo Pharma, Fdc Ltd, Watson Labs Inc, Rising Pharms Inc, Ivax Sub Teva Pharms, Watson Labs, Apotex, Amring Pharms, Bedford, Teva Pharms, Acs Dobfar Info Sa, and Baxter Hlthcare, and is included in forty-seven NDAs. It is available from four suppliers. Additional details are available on the CIPROFLOXACIN profile page.

The generic ingredient in CIPROFLOXACIN is ciprofloxacin hydrochloride. There are thirty-one drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

Summary for NDA: 078062

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

Pharmacology for NDA: 078062

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 078062

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN
ciprofloxacin
INJECTABLE;INJECTION 078062 ANDA Pfizer Labs, Division of Pfizer Inc 0069-3241 0069-3241-22 10 CARTON in 1 CASE (0069-3241-22) > 1 VIAL in 1 CARTON (0069-3241-15) > 20 mL in 1 VIAL
CIPROFLOXACIN
ciprofloxacin
INJECTABLE;INJECTION 078062 ANDA Pfizer Labs, Division of Pfizer Inc 0069-3342 0069-3342-22 10 CARTON in 1 CASE (0069-3342-22) > 1 VIAL in 1 CARTON (0069-3342-15) > 40 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/20ML (10MG/ML)
Approval Date:Apr 29, 2008TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength400MG/40ML (10MG/ML)
Approval Date:Apr 29, 2008TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
AstraZeneca
US Army
Express Scripts
QuintilesIMS
Queensland Health
Argus Health
Julphar
Johnson and Johnson
Cipla

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