➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
McKesson
Moodys
Merck
Johnson and Johnson

Last Updated: June 19, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077568


Email this page to a colleague

« Back to Dashboard

NDA 077568 describes CIPROFLOXACIN HYDROCHLORIDE, which is a drug marketed by Akorn, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Ani Pharms Inc, Aurobindo Pharma, Barr, Carlsbad, Chartwell, Dr Reddys Labs Ltd, Fosun Pharma, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique Pharm Labs, Watson Labs, and Yiling, and is included in twenty-seven NDAs. It is available from fifty-two suppliers. Additional details are available on the CIPROFLOXACIN HYDROCHLORIDE profile page.

The generic ingredient in CIPROFLOXACIN HYDROCHLORIDE is ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 077568
Tradename:CIPROFLOXACIN HYDROCHLORIDE
Applicant:Fdc Ltd
Ingredient:ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077568
Suppliers and Packaging for NDA: 077568
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 077568 ANDA medsource pharmaceuticals 45865-979 45865-979-01 1 BOTTLE, PLASTIC in 1 CARTON (45865-979-01) > 5 mL in 1 BOTTLE, PLASTIC
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 077568 ANDA medsource pharmaceuticals 45865-994 45865-994-01 1 BOTTLE, PLASTIC in 1 CARTON (45865-994-01) > 2.5 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.3% BASE
Approval Date:Jun 30, 2008TE:ATRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Harvard Business School
AstraZeneca
Boehringer Ingelheim
Colorcon

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. 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.