Details for New Drug Application (NDA): 019847

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NDA 019847 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, Sentiss, Sun Pharm, Ani Pharms, Dr Reddys Labs Ltd, Endo Operations, Fosun Pharma, Rising, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rubicon, Sciegen Pharms Inc, The J Molner, Watson Labs Inc, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Natco, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms, and is included in sixty 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. Ten suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

Summary for 019847

Tradename:	CIPRO
Applicant:	Bayer Hlthcare
Ingredient:	ciprofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 019847

Anti-Bacterial Agents
Cytochrome P-450 CYP1A2 Inhibitors
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	400MG/40ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 26, 1990	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	200MG/20ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 26, 1990	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1200MG/120ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 26, 1990	TE:		RLD:	No

Expired US Patents for NDA 019847

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	CIPRO	ciprofloxacin	INJECTABLE;INJECTION	019847-001	Dec 26, 1990	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO	ciprofloxacin	INJECTABLE;INJECTION	019847-001	Dec 26, 1990	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO	ciprofloxacin	INJECTABLE;INJECTION	019847-001	Dec 26, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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