Details for New Drug Application (NDA): 205703

✉ Email this page to a colleague

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 two 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. Twelve suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.

Summary for 205703

Tradename:	ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER
Applicant:	Hq Spclt Pharma
Ingredient:	esmolol hydrochloride
Patents:	2

Pharmacology for NDA: 205703

Mechanism of Action	Adrenergic 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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	2.5GM/250ML (10MG/ML)
Approval Date:	Apr 7, 2016	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 15, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Mar 15, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	2GM/100ML (20MG/ML)
Approval Date:	Apr 7, 2016	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 15, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 205703

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703-002	Apr 7, 2016	⤷ Sign Up	⤷ Sign Up
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703-001	Apr 7, 2016	⤷ Sign Up	⤷ Sign Up
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703-002	Apr 7, 2016	⤷ Sign Up	⤷ Sign Up
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703-001	Apr 7, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.