Details for New Drug Application (NDA): 020258

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NDA 020258 describes IOPIDINE, which is a drug marketed by Harrow Eye and is included in two NDAs. It is available from two suppliers. Additional details are available on the IOPIDINE profile page.

The generic ingredient in IOPIDINE is apraclonidine hydrochloride. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apraclonidine hydrochloride profile page.

Summary for 020258

Tradename:	IOPIDINE
Applicant:	Harrow Eye
Ingredient:	apraclonidine hydrochloride
Patents:	0

Suppliers and Packaging for NDA: 020258

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020258	NDA AUTHORIZED GENERIC	Sandoz Inc	61314-665	61314-665-05	5 mL in 1 BOTTLE (61314-665-05)
IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020258	NDA AUTHORIZED GENERIC	Sandoz Inc	61314-665	61314-665-10	10 mL in 1 BOTTLE (61314-665-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.5% BASE
Approval Date:	Jul 30, 1993	TE:	AT	RLD:	Yes

Expired US Patents for NDA 020258

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020258-001	Jul 30, 1993	4,517,199	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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