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Covington
UBS
Julphar
Teva
Cerilliant
McKinsey
McKesson
Harvard Business School
Deloitte

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083590

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NDA 083590 describes NAPHAZOLINE HYDROCHLORIDE, which is a drug marketed by Akorn Inc and Altaire Pharms Inc and is included in three NDAs. It is available from three suppliers. Additional details are available on the NAPHAZOLINE HYDROCHLORIDE profile page.

The generic ingredient in NAPHAZOLINE HYDROCHLORIDE is naphazoline hydrochloride; pheniramine maleate. There are seven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the naphazoline hydrochloride; pheniramine maleate profile page.
Summary for 083590
Tradename:NAPHAZOLINE HYDROCHLORIDE
Applicant:Akorn Inc
Ingredient:naphazoline hydrochloride
Patents:0
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 083590
Suppliers and Packaging for NDA: 083590
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPHAZOLINE HYDROCHLORIDE naphazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 083590 ANDA Rebel Distributors Corp. 21695-915 E 21695-915-15
NAPHAZOLINE HYDROCHLORIDE naphazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 083590 ANDA Proficient Rx LP 63187-412 E 63187-412-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Citi
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Cantor Fitzgerald
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