Details for New Drug Application (NDA): 019779

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NDA 019779 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 019779

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

Pharmacology for NDA: 019779

Mechanism of Action	Adrenergic alpha-Agonists

Suppliers and Packaging for NDA: 019779

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019779	NDA	Harrow Eye, LLC	82667-200	82667-200-01	12 POUCH in 1 CARTON (82667-200-01) / 2 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 1% BASE
Approval Date:	Dec 31, 1987	TE:		RLD:	Yes

Expired US Patents for NDA 019779

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019779-001	Dec 31, 1987	⤷ Sign Up	⤷ Sign Up
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019779-001	Dec 31, 1987	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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