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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 217227

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NDA 217227 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 217227

Tradename:	TETRACAINE HYDROCHLORIDE
Applicant:	Somerset Theraps Llc
Ingredient:	tetracaine hydrochloride
Patents:	0

Pharmacology for NDA: 217227

Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for 217227

Anesthetics, Local

Suppliers and Packaging for NDA: 217227

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TETRACAINE HYDROCHLORIDE	tetracaine hydrochloride	SOLUTION;OPHTHALMIC	217227	ANDA	Somerset Therapeutics, LLC	70069-596	70069-596-01	1 BOTTLE in 1 CARTON (70069-596-01) / 5 mL in 1 BOTTLE
TETRACAINE HYDROCHLORIDE	tetracaine hydrochloride	SOLUTION;OPHTHALMIC	217227	ANDA	Somerset Therapeutics, LLC	70069-597	70069-597-01	1 BOTTLE in 1 CARTON (70069-597-01) / 15 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;OPHTHALMIC			Strength	0.5%
Approval Date:	Dec 20, 2024	TE:	AB1	RLD:	No
Regulatory Exclusivity Expiration:	Jun 25, 2025
Regulatory Exclusivity Use:	COMPETITIVE GENERIC THERAPY

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