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Generated: March 18, 2019

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Details for New Drug Application (NDA): 205937

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NDA 205937 describes CYCLOPENTOLATE HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Alcon Pharms Ltd, and Sola Barnes Hind, and is included in four NDAs. It is available from one supplier. 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. Seven suppliers are listed for this compound. Additional details are available on the cyclopentolate hydrochloride profile page.
Summary for 205937
Applicant:Akorn Inc
Ingredient:cyclopentolate hydrochloride
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 205937
Suppliers and Packaging for NDA: 205937
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOPENTOLATE HYDROCHLORIDE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 205937 ANDA Akorn, Inc. 17478-096 17478-096-15 1 BOTTLE, DROPPER in 1 CARTON (17478-096-15) > 15 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Dec 9, 2015TE:ATRLD:No

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