Details for New Drug Application (NDA): 019857

NDA 019857 describes CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Bayer Hlthcare and is included in one NDA. Additional details are available on the CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER is ciprofloxacin. There are thirty-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ciprofloxacin profile page.

Summary for 019857

Tradename:	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:	Bayer Hlthcare
Ingredient:	ciprofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 019857

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INJECTABLE;INJECTION			Strength	200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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INJECTABLE;INJECTION			Strength	400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Dec 26, 1990	TE:		RLD:	Yes

Expired US Patents for NDA 019857

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990

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