Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Chubb
Colorcon
Julphar
Teva
UBS
Cipla
AstraZeneca
McKinsey
Novartis
Farmers Insurance

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204300

« Back to Dashboard
NDA 204300 describes VAZCULEP, which is a drug marketed by Avadel Legacy and is included in one NDA. It is available from one supplier. Additional details are available on the VAZCULEP profile page.

The generic ingredient in VAZCULEP is phenylephrine hydrochloride. There are twenty drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride profile page.

Summary for NDA: 204300

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204300

Mechanism of ActionAdrenergic alpha1-Agonists

Suppliers and Packaging for NDA: 204300

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VAZCULEP
phenylephrine hydrochloride
SOLUTION;IV (INFUSION) 204300 NDA Avadel Legacy Pharmaceuticals, LLC 76014-004 76014-004-10 10 CARTON in 1 CELLO PACK (76014-004-10) > 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (76014-004-32) > 5 mL in 1 VIAL, PHARMACY BULK PACKAGE
VAZCULEP
phenylephrine hydrochloride
SOLUTION;IV (INFUSION) 204300 NDA Avadel Legacy Pharmaceuticals, LLC 76014-004 76014-004-25 25 VIAL, SINGLE-DOSE in 1 CARTON (76014-004-25) > 1 mL in 1 VIAL, SINGLE-DOSE (76014-004-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength10MG/ML (10MG/ML)
Approval Date:Jun 27, 2014TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength50MG/5ML (10MG/ML)
Approval Date:Jun 27, 2014TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength100MG/10ML (10MG/ML)
Approval Date:Jun 27, 2014TE:RLD:Yes


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Novartis
Argus Health
US Army
Boehringer Ingelheim
Merck
Cantor Fitzgerald
QuintilesIMS
Accenture
Cipla
Teva

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot