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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 040315

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NDA 040315 describes TROPICACYL, which is a drug marketed by Akorn and is included in two NDAs. It is available from two 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. Six suppliers are listed for this compound. Additional details are available on the tropicamide profile page.
Summary for 040315
Formulation / Manufacturing:see details
Pharmacology for NDA: 040315
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 040315
Suppliers and Packaging for NDA: 040315
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TROPICACYL tropicamide SOLUTION/DROPS;OPHTHALMIC 040315 ANDA Henry Schein Inc. 0404-7192 0404-7192-01 1 BOTTLE, DROPPER in 1 CARTON (0404-7192-01) > 15 mL in 1 BOTTLE, DROPPER
TROPICACYL tropicamide SOLUTION/DROPS;OPHTHALMIC 040315 ANDA Akorn, Inc. 17478-102 17478-102-12 1 BOTTLE, DROPPER in 1 CARTON (17478-102-12) > 15 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength1%
Approval Date:Sep 29, 2000TE:ATRLD:No

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Johnson and Johnson

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