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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 207524

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NDA 207524 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 207524

Tradename:	TROPICAMIDE
Applicant:	Somerset Theraps Llc
Ingredient:	tropicamide
Patents:	0

Pharmacology for NDA: 207524

Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 207524

Muscarinic Antagonists
Mydriatics

Suppliers and Packaging for NDA: 207524

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TROPICAMIDE	tropicamide	SOLUTION/DROPS;OPHTHALMIC	207524	ANDA	Somerset Therapeutics, LLC	70069-121	70069-121-01	1 BOTTLE in 1 CARTON (70069-121-01) / 15 mL in 1 BOTTLE
TROPICAMIDE	tropicamide	SOLUTION/DROPS;OPHTHALMIC	207524	ANDA	ASCLEMED USA INC.	76420-438	76420-438-15	1 BOTTLE in 1 CARTON (76420-438-15) / 15 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	1%
Approval Date:	Dec 12, 2019	TE:	AT	RLD:	No

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