Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

How our clients use DrugPatentWatch

Generated: May 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083590

« Back to Dashboard
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 six 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. Fourteen suppliers are listed for this compound. Additional details are available on the naphazoline hydrochloride; pheniramine maleate profile page.

Summary for NDA: 083590

Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 083590

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
naphazoline hydrochloride
SOLUTION/DROPS;OPHTHALMIC 083590 ANDA Akorn, Inc. 17478-216 17478-216-12 1 BOTTLE, DROPPER in 1 CARTON (17478-216-12) > 15 mL in 1 BOTTLE, DROPPER
naphazoline hydrochloride
SOLUTION/DROPS;OPHTHALMIC 083590 ANDA Rebel Distributors Corp. 21695-915 21695-915-15 15 mL in 1 BOTTLE, PLASTIC (21695-915-15)

Summary for product number 001

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

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How our clients use DrugPatentWatch

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted

Follow DrugPatentWatch:

Google Plus