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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 208135


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NDA 208135 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 208135
Tradename:TETRACAINE HYDROCHLORIDE
Applicant:Alcon Labs
Ingredient:tetracaine hydrochloride
Patents:0
Pharmacology for NDA: 208135
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for 208135
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 REMEDYREPACK INC. 70518-4183 70518-4183-0 12 BOTTLE, DROPPER in 1 CARTON (70518-4183-0) / 4 mL in 1 BOTTLE, DROPPER (70518-4183-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;OPHTHALMICStrength0.5%
Approval Date:Feb 29, 2016TE:RLD:Yes

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