Details for New Drug Application (NDA): 019537

NDA 019537 describes CIPRO, which is a drug marketed by Bayer Hlthcare, Sandoz, Bayer Pharms, Chartwell, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Amneal, Sentiss, Sun Pharm, Ani Pharms, Dr Reddys Labs Ltd, Fosun Pharma, Ph Health, Rising, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Pharmobedient, Rubicon Research, The J Molner, Watson Labs Inc, New Heightsrx, Aiping Pharm Inc, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Natco, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, Cosette Pharms Nc, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms, and is included in sixty-two NDAs. It is available from one supplier. There is one patent 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. Nine 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

Pharmacology for NDA: 019537

Mechanism of Action

Cytochrome P450 1A2 Inhibitors

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 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 250MG BASE
Approval Date:	Oct 22, 1987	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 500MG BASE
Approval Date:	Oct 22, 1987	TE:	AB	RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Oct 22, 1987	TE:		RLD:	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	019537-002	Oct 22, 1987
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-004	Oct 22, 1987
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-003	Oct 22, 1987
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-004	Oct 22, 1987
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-003	Oct 22, 1987
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-002	Oct 22, 1987

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