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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Deloitte
Harvard Business School
Accenture
Express Scripts
Moodys
Mallinckrodt
Fuji
Colorcon
Fish and Richardson
Baxter

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084300

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NDA 084300 describes CYCLOMYDRIL, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. Additional details are available on the CYCLOMYDRIL profile page.

The generic ingredient in CYCLOMYDRIL is cyclopentolate hydrochloride; phenylephrine hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cyclopentolate hydrochloride; phenylephrine hydrochloride profile page.

Summary for 084300

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

Pharmacology for NDA: 084300

Mechanism of ActionAdrenergic alpha1-Agonists

Suppliers and Packaging for NDA: 084300

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOMYDRIL cyclopentolate hydrochloride; phenylephrine hydrochloride SOLUTION/DROPS;OPHTHALMIC 084300 ANDA Alcon Laboratories, Inc. 0065-0359 0065-0359-02 2 mL in 1 BOTTLE, PLASTIC (0065-0359-02)
CYCLOMYDRIL cyclopentolate hydrochloride; phenylephrine hydrochloride SOLUTION/DROPS;OPHTHALMIC 084300 ANDA Alcon Laboratories, Inc. 0065-0359 0065-0359-05 5 mL in 1 BOTTLE, PLASTIC (0065-0359-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.2%;1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Baxter
Federal Trade Commission
US Army
McKesson
Cantor Fitzgerald
Citi
Teva
Harvard Business School
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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