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Last Updated: April 25, 2024

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 ActionAdrenergic 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:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 1% BASE
Approval Date:Dec 31, 1987TE:RLD:Yes

Expired US Patents for NDA 019779

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

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