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Last Updated: July 25, 2024

Details for New Drug Application (NDA): 077568

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NDA 077568 describes CIPROFLOXACIN HYDROCHLORIDE, which is a drug marketed by Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Pai Holdings Pharm, Rising, Rubicon, Saptalis Pharms, 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 fifty-one 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-six suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 077568
Applicant:Fdc Ltd
Ingredient:ciprofloxacin hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 077568
Mechanism of ActionCytochrome P450 1A2 Inhibitors
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 45865-994 45865-994-01 1 BOTTLE, PLASTIC in 1 CARTON (45865-994-01) / 2.5 mL in 1 BOTTLE, PLASTIC
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 077568 ANDA A-S Medication Solutions 50090-4217 50090-4217-0 1 BOTTLE, PLASTIC in 1 CARTON (50090-4217-0) / 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

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