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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 208921


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NDA 208921 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 208921
Tradename:CIPROFLOXACIN HYDROCHLORIDE
Applicant:Yiling
Ingredient:ciprofloxacin hydrochloride
Patents:0
Pharmacology for NDA: 208921
Mechanism of ActionCytochrome P450 1A2 Inhibitors
Suppliers and Packaging for NDA: 208921
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 208921 ANDA Solco Healthcare US, LLC 43547-688 43547-688-10 100 TABLET in 1 BOTTLE (43547-688-10)
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 208921 ANDA Solco Healthcare US, LLC 43547-689 43547-689-10 100 TABLET in 1 BOTTLE (43547-689-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Jun 22, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Jun 22, 2018TE:ABRLD:No

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