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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210821

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NDA 210821 describes TETRACAINE HYDROCHLORIDE, which is a drug marketed by Alcon Labs, Bausch Lomb Ireland, and Somerset Theraps Llc, and is included in three NDAs. It is available from eight 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. Eight 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 Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for 210821

Anesthetics, Local

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:	RX	Dosage:	SOLUTION;OPHTHALMIC			Strength	0.5%
Approval Date:	Mar 12, 2019	TE:	AB1	RLD:	Yes

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