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Generated: April 22, 2018

DrugPatentWatch Database Preview

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 is included in one NDA. It is available from one supplier. 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. One supplier is 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 208135
Ingredient-typeEsters
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 N 0065-0741-12
TETRACAINE HYDROCHLORIDE tetracaine hydrochloride SOLUTION;OPHTHALMIC 208135 NDA Alcon Laboratories, Inc. 0065-0741 N 0065-0741-14

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
McKesson
Colorcon
Julphar
Chubb
Boehringer Ingelheim
Argus Health
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