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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Dow
Cipla
Boehringer Ingelheim
Merck
Queensland Health
Chubb
Colorcon
Harvard Business School

Generated: December 17, 2017

DrugPatentWatch Database Preview

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 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 040315

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Boehringer Ingelheim
Julphar
Cerilliant
Healthtrust
Merck
Mallinckrodt
Johnson and Johnson
Cantor Fitzgerald
Covington

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