You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Details for New Drug Application (NDA): 076126


✉ Email this page to a colleague

« Back to Dashboard


NDA 076126 describes CIPROFLOXACIN HYDROCHLORIDE, which is a drug marketed by Akorn, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Pai Holdings Pharm, Rising, Rubicon, Watson Labs Inc, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Chartwell, Dr Reddys Labs Ltd, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, and Yiling, and is included in twenty-seven NDAs. It is available from forty-nine 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-two suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 076126
Tradename:CIPROFLOXACIN HYDROCHLORIDE
Applicant:Carlsbad
Ingredient:ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076126
Mechanism of ActionCytochrome P450 1A2 Inhibitors
Suppliers and Packaging for NDA: 076126
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076126 ANDA PD-Rx Pharmaceuticals, Inc. 43063-547 43063-547-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-01)
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076126 ANDA PD-Rx Pharmaceuticals, Inc. 43063-547 43063-547-02 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-02)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Jun 9, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Jun 9, 2004TE:ABRLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 750MG BASE
Approval Date:Jun 9, 2004TE:ABRLD:No

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. 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.