Orange Book product · Brand (NDA)

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

NOREPINEPHRINE BITARTRATE

Brand (NDA)NDA 214628RX LONG GROVE PHARMS

Oct 06, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 06, 2022
3 yr 9 mo ago
Today
Patent 10159657 expires
Listed drug product patent expiration.
Jan 30, 2038
in 11 yr 9 mo
Patent 10226436 expires
Listed drug product patent expiration.
Jan 30, 2038
in 11 yr 9 mo
Patent 10420735 expires
Listed drug product patent expiration.
Jan 30, 2038
in 11 yr 9 mo
Patent 10568850 expires
Listed drug product patent expiration.
Jan 30, 2038
in 11 yr 9 mo
Patent 11413259 expires
Listed drug product patent expiration.
Jan 30, 2038
in 11 yr 9 mo
Patent 11602508 expires
Listed drug product patent expiration.
Jan 30, 2038
in 11 yr 9 mo
Patent 12245996 expires
Listed drug product patent expiration.
Jan 30, 2038
in 11 yr 9 mo

Active ingredient

NOREPINEPHRINE BITARTRATE

Strength

EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 214628

Product number

001

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
10159657	Jan 30, 2038	in 11 yr 9 mo	Product
10226436	Jan 30, 2038	in 11 yr 9 mo	ProductU-3461
10420735	Jan 30, 2038	in 11 yr 9 mo	ProductU-3461
10568850	Jan 30, 2038	in 11 yr 9 mo	Product
11413259	Jan 30, 2038	in 11 yr 9 mo	ProductU-3461
11602508	Jan 30, 2038	in 11 yr 9 mo	Product
12245996	Jan 30, 2038	in 11 yr 9 mo	Product