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Generated: December 15, 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 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, Mylan Pharms Inc, Sandoz, 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, Acs Dobfar Info Sa, Baxter Hlthcare, Bedford, 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

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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