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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Medtronic
Cerilliant
Chinese Patent Office
Covington
US Army
Daiichi Sankyo
Accenture
McKinsey

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203510

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NDA 203510 describes PHENYLEPHRINE HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Paragon Bioteck, Cipla Ltd, West Ward Pharm Corp, Hi-tech Pharmacal, and Vintage, and is included in seven NDAs. It is available from seven suppliers. There is one patent protecting this drug. Additional details are available on the PHENYLEPHRINE HYDROCHLORIDE profile page.

The generic ingredient in PHENYLEPHRINE HYDROCHLORIDE is phenylephrine hydrochloride; promethazine hydrochloride. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 203510
Tradename:PHENYLEPHRINE HYDROCHLORIDE
Applicant:Paragon Bioteck
Ingredient:phenylephrine hydrochloride
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203510
Mechanism of ActionAdrenergic alpha1-Agonists
Suppliers and Packaging for NDA: 203510
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION/DROPS;OPHTHALMIC 203510 NDA Paragon BioTeck, Inc. 42702-102 N 42702-102-15
PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION/DROPS;OPHTHALMIC 203510 NDA Paragon BioTeck, Inc. 42702-103 N 42702-103-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength2.5%
Approval Date:Mar 21, 2013TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 14, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:DILATION OF THE PUPIL

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength10%
Approval Date:Mar 21, 2013TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 14, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:DILATION OF THE PUPIL

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Teva
Mallinckrodt
Fuji
Chinese Patent Office
Fish and Richardson
Moodys
Argus Health
Farmers Insurance

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