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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 089162


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NDA 089162 describes CYCLOPENTOLATE HYDROCHLORIDE, which is a drug marketed by Akorn, Alcon Pharms Ltd, 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 089162
Tradename:CYCLOPENTOLATE HYDROCHLORIDE
Applicant:Alcon Pharms Ltd
Ingredient:cyclopentolate hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 089162

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrength1%
Approval Date:Jan 24, 1991TE:RLD:No

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