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Serving 500+ biopharmaceutical companies globally:

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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020258

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NDA 020258 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 NDA: 020258

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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
Novartis Pharms Corp
IOPIDINE
apraclonidine hydrochloride
SOLUTION/DROPS;OPHTHALMIC020258-001Jul 30, 19934,517,199► Subscribe
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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
McKesson
Cipla
McKinsey
AstraZeneca
UBS
Deloitte
Medtronic
Fish and Richardson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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