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Last Updated: October 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019537

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NDA 019537 describes CIPRO, which is a drug marketed by Bayer Hlthcare, Novartis Pharms Corp, Bayer Pharms, Lupin Ltd, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Anchen Pharms, Ani Pharms Inc, Dr Reddys Labs Ltd, Fosun Pharma, Mylan Pharms Inc, Akorn Inc, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Aurobindo Pharma, Barr, Carlsbad, Chartwell Molecules, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique Pharm Labs, Watson Labs, Yiling Pharm Ltd, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms, and is included in fifty-seven 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-four 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 019537
Tradename:CIPRO
Applicant:Bayer Hlthcare
Ingredient:ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019537
Suppliers and Packaging for NDA: 019537
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-754 50419-754-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-754-01)
CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-758 50419-758-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-758-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Apr 8, 1996TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Oct 22, 1987TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Oct 22, 1987TE:ABRLD:Yes

Expired US Patents for NDA 019537

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-003 Oct 22, 1987   See Pricing   See Pricing
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-001 Apr 8, 1996   See Pricing   See Pricing
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-004 Oct 22, 1987   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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