BioPharmaceutical Business Intelligence

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
Express Scripts
Harvard Business School
Federal Trade Commission

Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078062

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NDA 078062 describes CIPROFLOXACIN, which is a drug marketed by Lupin Ltd, Baxter Hlthcare Corp, Bedford Labs, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Teva Pharms Usa, Actavis Labs Fl Inc, Anchen Pharms, Dr Reddys Labs Ltd, Fosun Pharma, Mylan Pharms Inc, Akorn Inc, Amring Pharms, Apotex Inc, Fdc Ltd, Rising Pharms Inc, Teligent, Watson Labs Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Hikma, Idt Australia Ltd, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro Pharm, Teva, Unique Pharm Labs, Watson Labs, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms, 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-four suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 078062
Applicant:Baxter Hlthcare Corp
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 078062
Medical Subject Heading (MeSH) Categories for 078062
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 E 0069-3241-22
CIPROFLOXACIN ciprofloxacin INJECTABLE;INJECTION 078062 ANDA Pfizer Labs, Division of Pfizer Inc 0069-3342 E 0069-3342-22

Profile for product number 001

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

Profile 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 hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Express Scripts
Queensland Health
US Army

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