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Details for New Drug Application (NDA): 019847

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NDA 019847 describes CIPRO, which is a drug marketed by Bayer Hlthcare, Alcon Pharms Ltd, Bayer Pharms, 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 fifty-five NDAs. It is available from one supplier. There are eight patents protecting this drug and two Paragraph IV challenges. Additional details are available on the CIPRO profile page.

The generic ingredient in CIPRO is ciprofloxacin; dexamethasone. There are thirty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

Summary for NDA: 019847

Tradename:
CIPRO
Applicant:
Bayer Hlthcare
Ingredient:
ciprofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength400MG/40ML (10MG/ML)
Approval Date:Dec 26, 1990TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/20ML (10MG/ML)
Approval Date:Dec 26, 1990TE:APRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1200MG/120ML (10MG/ML)
Approval Date:Dec 26, 1990TE:RLD:No

Expired Orange Book Patents for NDA: 019847

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
CIPRO
ciprofloxacin
INJECTABLE;INJECTION019847-001Dec 26, 19904,670,444*PED► subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin
INJECTABLE;INJECTION019847-001Dec 26, 19904,808,583*PED► subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin
INJECTABLE;INJECTION019847-001Dec 26, 19904,705,789*PED► subscribe
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