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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 205937

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NDA 205937 describes CYCLOPENTOLATE HYDROCHLORIDE, which is a drug marketed by Alcon Pharms Ltd, Sciegen Pharms Inc, and Sola Barnes Hind, and is included in four NDAs. Additional details are available on the CYCLOPENTOLATE HYDROCHLORIDE profile page.

The generic ingredient in CYCLOPENTOLATE HYDROCHLORIDE is cyclopentolate hydrochloride. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cyclopentolate hydrochloride profile page.

Summary for 205937

Tradename:	CYCLOPENTOLATE HYDROCHLORIDE
Applicant:	Sciegen Pharms Inc
Ingredient:	cyclopentolate hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 205937

Muscarinic Antagonists
Mydriatics
Parasympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.5%
Approval Date:	Dec 9, 2015	TE:		RLD:	No

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