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Last Updated: June 22, 2021

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Details for New Drug Application (NDA): 020369

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NDA 020369 describes CILOXAN, which is a drug marketed by Novartis and is included in two NDAs. It is available from eight 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-eight suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 020369
Ingredient:ciprofloxacin hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 020369
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 Alcon Laboratories, Inc. 0065-0654 0065-0654-35 3.5 g in 1 TUBE (0065-0654-35)
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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson

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