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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 084863

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NDA 084863 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 084863

Tradename:	CYCLOPENTOLATE HYDROCHLORIDE
Applicant:	Sola Barnes Hind
Ingredient:	cyclopentolate hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 084863

Muscarinic Antagonists
Mydriatics
Parasympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	1%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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