Last Updated: May 3, 2026

Details for New Drug Application (NDA): 020780

✉ Email this page to a colleague

« Back to Dashboard

NDA 020780 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, Upsher Smith Labs, 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-three NDAs. It is available from one supplier. 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. Eleven suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

Summary for 020780

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

Medical Subject Heading (MeSH) Categories for 020780

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

Suppliers and Packaging for NDA: 020780

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-773	50419-773-01	1 KIT in 1 KIT (50419-773-01) * 100 mL in 1 BOTTLE, GLASS * 100 mL in 1 BOTTLE, GLASS
CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-777	50419-777-01	1 KIT in 1 KIT (50419-777-01) * 100 mL in 1 BOTTLE, GLASS * 100 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	250MG/5ML
Approval Date:	Sep 26, 1997	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	500MG/5ML
Approval Date:	Sep 26, 1997	TE:	AB	RLD:	Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.