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Details for New Drug Application (NDA): 078062

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NDA 078062 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 drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

Summary for NDA: 078062

Therapeutic Class:Antibacterials

Pharmacology for NDA: 078062


Suppliers and Packaging for NDA: 078062

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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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