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Details for New Drug Application (NDA): 020258

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NDA 020258 describes IOPIDINE, which is a drug marketed by Alcon 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 NDA: 020258

Tradename:
IOPIDINE
Applicant:
Alcon
Ingredient:
apraclonidine hydrochloride
Patents:0
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 020258

Mechanism of ActionAdrenergic alpha-Agonists

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 Alcon Laboratories, Inc. 0065-0665 0065-0665-05 5 mL in 1 BOTTLE (0065-0665-05)
IOPIDINE
apraclonidine hydrochloride
SOLUTION/DROPS;OPHTHALMIC 020258 NDA Alcon Laboratories, Inc. 0065-0665 0065-0665-10 10 mL in 1 BOTTLE (0065-0665-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Jul 30, 1993TE:ATRLD:Yes

Expired Orange Book Patents for NDA: 020258

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alcon
IOPIDINE
apraclonidine hydrochloride
SOLUTION/DROPS;OPHTHALMIC020258-001Jul 30, 19934,517,199► subscribe
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