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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210821


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NDA 210821 describes TETRACAINE HYDROCHLORIDE, which is a drug marketed by Alcon Labs and Bausch Lomb Ireland and is included in two NDAs. It is available from six suppliers. Additional details are available on the TETRACAINE HYDROCHLORIDE profile page.

The generic ingredient in TETRACAINE HYDROCHLORIDE is tetracaine hydrochloride. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tetracaine hydrochloride profile page.
Summary for 210821
Tradename:TETRACAINE HYDROCHLORIDE
Applicant:Bausch Lomb Ireland
Ingredient:tetracaine hydrochloride
Patents:0
Pharmacology for NDA: 210821
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for 210821
Suppliers and Packaging for NDA: 210821
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TETRACAINE HYDROCHLORIDE tetracaine hydrochloride SOLUTION;OPHTHALMIC 210821 NDA Bausch Health US LLC 0187-0920 0187-0920-05 1 BOTTLE in 1 CARTON (0187-0920-05) / 5 mL in 1 BOTTLE
TETRACAINE HYDROCHLORIDE tetracaine hydrochloride SOLUTION;OPHTHALMIC 210821 NDA Bausch & Lomb Incorporated 24208-092 24208-092-05 1 BOTTLE, DROPPER in 1 CARTON (24208-092-05) / 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;OPHTHALMICStrength0.5%
Approval Date:Mar 12, 2019TE:RLD:Yes

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