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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205703

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NDA 205703 describes ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER, which is a drug marketed by Hq Spclt Pharma and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER profile page.

The generic ingredient in ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER is esmolol hydrochloride. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.

Summary for 205703

Tradename:2
Applicant:1
Ingredient:1
Patents:4
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 205703

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 205703

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER esmolol hydrochloride SOLUTION;INTRAVENOUS 205703 NDA WG Critical Care, LLC 44567-811 44567-811-10 10 BAG in 1 CARTON (44567-811-10) > 250 mL in 1 BAG
ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER esmolol hydrochloride SOLUTION;INTRAVENOUS 205703 NDA WG Critical Care, LLC 44567-811 44567-811-10 10 BAG in 1 CARTON (44567-811-10) > 250 mL in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength2.5GM/250ML (10MG/ML)
Approval Date:Apr 7, 2016TE:RLD:Yes
Patent:► SubscribePatent Expiration:Jan 12, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Jan 12, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Mar 15, 2033Product Flag?YSubstance Flag?Delist Request?


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