Orange Book product · Brand (NDA)

ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER

ESMOLOL HYDROCHLORIDE

Brand (NDA)NDA 205703RX HQ SPCLT PHARMA

Apr 07, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 07, 2016
10 yr 4 mo ago
Today
Patent 8829054 expires
Listed drug product patent expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 8835505 expires
Listed drug product patent expiration.
Mar 15, 2033
in 6 yr 10 mo

Active ingredient

ESMOLOL HYDROCHLORIDE

Strength

2GM/100ML (20MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 205703

Product number

002

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8829054	Mar 15, 2033	in 6 yr 10 mo	Product
8835505	Mar 15, 2033	in 6 yr 10 mo	Product