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Details for New Drug Application (NDA): 204300

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NDA 204300 describes VAZCULEP, which is a drug marketed by Eclat Pharms Llc 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:
VAZCULEP
Applicant:
Eclat Pharms Llc
Ingredient:
phenylephrine hydrochloride
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 Éclat 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 Éclat 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:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength50MG/5ML (10MG/ML)
Approval Date:Jun 27, 2014TE:RLD:No

Summary for product number 003

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


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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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