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Last Updated: July 5, 2020

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Details for New Drug Application (NDA): 080027

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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. Eight suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.
Summary for 080027
Applicant:Alcon Labs Inc
Ingredient:proparacaine hydrochloride
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 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

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