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Generated: December 12, 2017

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, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Teva Pharms Usa, Actavis Labs Fl Inc, Anchen Pharms, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz, Akorn Inc, Amring Pharms, Apotex Inc, Fdc Ltd, Rising Pharms Inc, Teligent, Watson Labs Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Hikma, Idt Australia Ltd, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro Pharm, Teva, Unique Pharm Labs, Watson Labs, Acs Dobfar Info Sa, Baxter Hlthcare, Bedford, and Teva Pharms, 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. Four suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

Summary for 019537

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 019537

Ingredient-typeQuinolones

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)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 019537

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer HlthcareCIPROciprofloxacin hydrochlorideTABLET;ORAL019537-004Oct 22, 1987► Subscribe► Subscribe
Bayer HlthcareCIPROciprofloxacin hydrochlorideTABLET;ORAL019537-001Apr 8, 1996► Subscribe► Subscribe
Bayer HlthcareCIPROciprofloxacin hydrochlorideTABLET;ORAL019537-004Oct 22, 1987► Subscribe► Subscribe
Bayer HlthcareCIPROciprofloxacin hydrochlorideTABLET;ORAL019537-003Oct 22, 1987► Subscribe► Subscribe
Bayer HlthcareCIPROciprofloxacin hydrochlorideTABLET;ORAL019537-002Oct 22, 1987► Subscribe► Subscribe
Bayer HlthcareCIPROciprofloxacin hydrochlorideTABLET;ORAL019537-003Oct 22, 1987► Subscribe► Subscribe
Bayer HlthcareCIPROciprofloxacin hydrochlorideTABLET;ORAL019537-002Oct 22, 1987► Subscribe► Subscribe
Bayer HlthcareCIPROciprofloxacin hydrochlorideTABLET;ORAL019537-001Apr 8, 1996► Subscribe► Subscribe
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Argus Health
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