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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Cantor Fitzgerald
Queensland Health
Daiichi Sankyo

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203826

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NDA 203826 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 203826
Applicant:West Ward Pharm Corp
Ingredient:phenylephrine hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203826
Mechanism of ActionAdrenergic alpha1-Agonists
Suppliers and Packaging for NDA: 203826
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;IV (INFUSION) 203826 NDA West-Ward Pharmaceutical Corp. 0641-6142 N 0641-6142-25
PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;IV (INFUSION) 203826 NDA General Injectables & Vaccines, Inc 52584-142 N 52584-142-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength10MG/ML (10MG/ML)
Approval Date:Dec 20, 2012TE:APRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
Boehringer Ingelheim
Harvard Business School
Chinese Patent Office

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