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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
Johnson and Johnson
Colorcon
McKesson
Express Scripts
Julphar
Cerilliant
QuintilesIMS
Merck

Generated: January 21, 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 six drug master file entries for this compound. Fifteen 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 21695-915-15 15 mL in 1 BOTTLE, PLASTIC (21695-915-15)
NAPHAZOLINE HYDROCHLORIDE naphazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 083590 ANDA Proficient Rx LP 63187-412 63187-412-15 1 BOTTLE, DROPPER in 1 CARTON (63187-412-15) > 15 mL in 1 BOTTLE, DROPPER

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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Serving leading biopharmaceutical companies globally:

Queensland Health
Merck
Deloitte
Citi
Teva
Medtronic
Baxter
Federal Trade Commission
Boehringer Ingelheim

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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