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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 020369


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NDA 020369 describes CILOXAN, which is a drug marketed by Sandoz and is included in two NDAs. It is available from ten suppliers. Additional details are available on the CILOXAN profile page.

The generic ingredient in CILOXAN 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 020369
Tradename:CILOXAN
Applicant:Sandoz
Ingredient:ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020369
Mechanism of ActionCytochrome P450 1A2 Inhibitors
Suppliers and Packaging for NDA: 020369
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CILOXAN ciprofloxacin hydrochloride OINTMENT;OPHTHALMIC 020369 NDA Novartis Pharmaceuticals Corporation 0078-0841 0078-0841-01 3.5 g in 1 TUBE (0078-0841-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrengthEQ 0.3% BASE
Approval Date:Mar 30, 1998TE:RLD:Yes

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