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Generated: August 18, 2017

DrugPatentWatch Database Preview

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 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 NDA: 040314

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 040314

Mechanism of ActionCholinergic Antagonists

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

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Accenture
Johnson and Johnson
QuintilesIMS
McKinsey
Dow
Colorcon
Deloitte
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Queensland Health
Boehringer Ingelheim

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