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Generated: November 19, 2018

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Details for New Drug Application (NDA): 019779

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NDA 019779 describes IOPIDINE, which is a drug marketed by Novartis Pharms Corp 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. Three suppliers are listed for this compound. Additional details are available on the apraclonidine hydrochloride profile page.
Summary for 019779
Tradename:IOPIDINE
Applicant:Novartis Pharms Corp
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 Alcon Laboratories, Inc. 0065-0660 0065-0660-10 12 POUCH in 1 CARTON (0065-0660-10) > 2 VIAL, SINGLE-USE in 1 POUCH > .1 mL in 1 VIAL, SINGLE-USE

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
Novartis Pharms Corp IOPIDINE apraclonidine hydrochloride SOLUTION/DROPS;OPHTHALMIC 019779-001 Dec 31, 1987 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp IOPIDINE apraclonidine hydrochloride SOLUTION/DROPS;OPHTHALMIC 019779-001 Dec 31, 1987 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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