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Details for New Drug Application (NDA): 077245

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NDA 077245 describes CIPROFLOXACIN, which is a drug marketed by Hikma Farmaceutica, Hospira, Claris, 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, Mylan, Barr, Carlsbad, Pliva, Apotex Inc, Teva, Nostrum Labs, Idt Australia Ltd, Unique Pharm Labs, Sun Pharm Inds Ltd, Teligent Pharma Inc, Akorn Inc, Hikma, Aurobindo Pharma, Fdc Ltd, Watson Labs Inc, Rising Pharms Inc, Ivax Sub Teva Pharms, Watson Labs, Apotex, Pharmaforce, Bedford, Teva Pharms, Acs Dobfar Info Sa, and Baxter Hlthcare, and is included in forty-seven NDAs. It is available from five 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. Sixty-nine suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

Summary for NDA: 077245

Tradename:
CIPROFLOXACIN
Applicant:
Hospira
Ingredient:
ciprofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 077245

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 077245

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN
ciprofloxacin
INJECTABLE;INJECTION 077245 ANDA Hospira, Inc. 0409-4765 0409-4765-86 1 VIAL in 1 CARTON (0409-4765-86) > 20 mL in 1 VIAL
CIPROFLOXACIN
ciprofloxacin
INJECTABLE;INJECTION 077245 ANDA Hospira, Inc. 0409-4778 0409-4778-86 1 VIAL in 1 CARTON (0409-4778-86) > 40 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/20ML (10MG/ML)
Approval Date:Aug 28, 2006TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength400MG/40ML (10MG/ML)
Approval Date:Aug 28, 2006TE:APRLD:No


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