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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208135

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NDA 208135 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 208135

Tradename:	TETRACAINE HYDROCHLORIDE
Applicant:	Alcon Labs
Ingredient:	tetracaine hydrochloride
Patents:	0

Pharmacology for NDA: 208135

Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for 208135

Anesthetics, Local

Suppliers and Packaging for NDA: 208135

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TETRACAINE HYDROCHLORIDE	tetracaine hydrochloride	SOLUTION;OPHTHALMIC	208135	NDA	Alcon Laboratories, Inc.	0065-0741	0065-0741-14	12 BLISTER PACK in 1 CARTON (0065-0741-14) / 1 BOTTLE, DROPPER in 1 BLISTER PACK / 4 mL in 1 BOTTLE, DROPPER
TETRACAINE HYDROCHLORIDE	tetracaine hydrochloride	SOLUTION;OPHTHALMIC	208135	NDA	A-S Medication Solutions	50090-2364	50090-2364-1	4 mL in 1 BOTTLE, DROPPER (50090-2364-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;OPHTHALMIC			Strength	0.5%
Approval Date:	Feb 29, 2016	TE:		RLD:	Yes

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