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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 040064

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NDA 040064 describes TROPICAMIDE, which is a drug marketed by Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Miza Pharms Usa, Somerset Theraps Llc, and Watson Labs, and is included in eight NDAs. It is available from four suppliers. Additional details are available on the TROPICAMIDE profile page.

The generic ingredient in TROPICAMIDE is tropicamide. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tropicamide profile page.

Summary for 040064

Tradename:	TROPICAMIDE
Applicant:	Bausch And Lomb
Ingredient:	tropicamide
Patents:	0

Pharmacology for NDA: 040064

Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 040064

Muscarinic Antagonists
Mydriatics

Suppliers and Packaging for NDA: 040064

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TROPICAMIDE	tropicamide	SOLUTION/DROPS;OPHTHALMIC	040064	ANDA	Bausch & Lomb Incorporated	24208-585	24208-585-59	1 BOTTLE, DROPPER in 1 CARTON (24208-585-59) / 2 mL in 1 BOTTLE, DROPPER
TROPICAMIDE	tropicamide	SOLUTION/DROPS;OPHTHALMIC	040064	ANDA	Bausch & Lomb Incorporated	24208-585	24208-585-64	1 BOTTLE, DROPPER in 1 CARTON (24208-585-64) / 15 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	1%
Approval Date:	Jul 27, 1994	TE:	AT	RLD:	No

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