Orange Book product · Brand (NDA)

EMERPHED

EPHEDRINE SULFATE

Brand (NDA)NDA 213407RX NEXUS

Feb 28, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 28, 2023
3 yr 4 mo ago
Today
Patent 11464752 expires
Listed drug product patent expiration.
May 16, 2040
in 14 yr 1 mo
Patent 11571398 expires
Listed method-of-use patent (U-3183) expiration.
May 16, 2040
in 14 yr 1 mo

Active ingredient

EPHEDRINE SULFATE

Strength

25MG/5ML (5MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 213407

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
11464752	May 16, 2040	in 14 yr 1 mo	Product
11571398	May 16, 2040	in 14 yr 1 mo	U-3183