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Last Updated: June 16, 2021

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, Bayer Pharms, Chartwell, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Dr Reddys Labs Ltd, Anchen Pharms, Ani Pharms Inc, Fosun Pharma, Mylan Pharms Inc, Akorn, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique Pharm Labs, Watson Labs, Yiling, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms, and is included in fifty-seven NDAs. It is available from one supplier. There are six 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. Four 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)
Paragraph IV (Patent) Challenges for 019537
Tradename Dosage Ingredient NDA Submissiondate
CIPRO TABLET;ORAL ciprofloxacin hydrochloride 019537

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
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 019537-001 Apr 8, 1996   Get Started Free   Get Started Free
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-003 Oct 22, 1987   Get Started Free   Get Started Free
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-002 Oct 22, 1987   Get Started Free   Get Started Free
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-004 Oct 22, 1987   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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