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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Citi
Argus Health
Harvard Business School
Covington
Moodys
Federal Trade Commission
Express Scripts
Boehringer Ingelheim
McKesson

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084109

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NDA 084109 describes CYCLOGYL, which is a drug marketed by Novartis Pharms Corp and is included in three NDAs. It is available from two suppliers. Additional details are available on the CYCLOGYL profile page.

The generic ingredient in CYCLOGYL 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 084109
Tradename:CYCLOGYL
Applicant:Novartis Pharms Corp
Ingredient:cyclopentolate hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 084109
Suppliers and Packaging for NDA: 084109
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOGYL cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 084109 ANDA Alcon Laboratories, Inc. 0065-0395 0065-0395-15 1 BOTTLE, PLASTIC in 1 CARTON (0065-0395-15) > 15 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Novartis
US Army
Federal Trade Commission
Accenture
Healthtrust
Dow
Colorcon
US Department of Justice
Boehringer Ingelheim

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