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Generated: November 17, 2018

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Details for New Drug Application (NDA): 040314

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NDA 040314 describes TROPICACYL, which is a drug marketed by Akorn and is included in two NDAs. It is available from three suppliers. Additional details are available on the TROPICACYL profile page.

The generic ingredient in TROPICACYL is tropicamide. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tropicamide profile page.
Summary for 040314
Tradename:TROPICACYL
Applicant:Akorn
Ingredient:tropicamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040314
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 040314
Suppliers and Packaging for NDA: 040314
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TROPICACYL tropicamide SOLUTION/DROPS;OPHTHALMIC 040314 ANDA Akorn, Inc. 17478-101 17478-101-12 1 BOTTLE, DROPPER in 1 CARTON (17478-101-12) > 15 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Sep 29, 2000TE:ATRLD:No

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