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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 076896


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NDA 076896 describes CIPROFLOXACIN HYDROCHLORIDE, which is a drug marketed by Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Sciegen Pharms Inc, The J Molner, Watson Labs Inc, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Chartwell, Dr Reddys Labs Ltd, Hikma, Ivax Sub Teva Pharms, Natco, 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 fifty 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-five suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 076896
Tradename:CIPROFLOXACIN HYDROCHLORIDE
Applicant:Chartwell
Ingredient:ciprofloxacin hydrochloride
Patents:0
Pharmacology for NDA: 076896
Suppliers and Packaging for NDA: 076896
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076896 ANDA Chartwell RX, LLC. 62135-308 62135-308-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-308-01)
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076896 ANDA Chartwell RX, LLC. 62135-308 62135-308-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-308-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Nov 4, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Nov 4, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 750MG BASE
Approval Date:Nov 4, 2004TE:ABRLD:No

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