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 eleven 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-six 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

Pharmacology for NDA: 020369

Mechanism of Action	Cytochrome 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:	RX	Dosage:	OINTMENT;OPHTHALMIC			Strength	EQ 0.3% BASE
Approval Date:	Mar 30, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 020369

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	CILOXAN	ciprofloxacin hydrochloride	OINTMENT;OPHTHALMIC	020369-001	Mar 30, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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