You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 25, 2024

Details for New Drug Application (NDA): 080027


✉ Email this page to a colleague

« Back to Dashboard


NDA 080027 describes ALCAINE, which is a drug marketed by Alcon Labs Inc 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. Six suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.
Summary for 080027
Tradename:ALCAINE
Applicant:Alcon Labs Inc
Ingredient:proparacaine hydrochloride
Patents:0
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 Sandoz Inc. 61314-016 61314-016-01 1 BOTTLE in 1 CARTON (61314-016-01) / 15 mL in 1 BOTTLE

Profile 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

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.