Deeper Knowledge, Faster

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

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

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Queensland Health
US Department of Justice
Express Scripts

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080027

« Back to Dashboard

NDA 080027 describes ALCAINE, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from three suppliers. Additional details are available on the ALCAINE profile page.

The generic ingredient in ALCAINE is proparacaine hydrochloride. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.

Summary for 080027

Formulation / Manufacturing:see details

Pharmacology for NDA: 080027

Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 080027

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALCAINE proparacaine hydrochloride SOLUTION/DROPS;OPHTHALMIC 080027 ANDA Alcon Laboratories, Inc. 0998-0016 0998-0016-15 1 BOTTLE in 1 CARTON (0998-0016-15) > 15 mL in 1 BOTTLE
ALCAINE proparacaine hydrochloride SOLUTION/DROPS;OPHTHALMIC 080027 ANDA STAT Rx USA LLC 16590-195 16590-195-15 15 mL in 1 BOTTLE (16590-195-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

Complete Access Available with Subscription
« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Federal Trade Commission
Daiichi Sankyo
Argus Health
Farmers Insurance

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
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch: