Orange Book product · Brand (NDA)

EPHEDRINE SULFATE

Brand (NDA)NDA 213994TE AP2RX PH HEALTH

Apr 22, 2022

Approved

Brand (NDA)

Application

AP2

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 22, 2022
4 yr 3 mo ago
Today
Patent 10869845 expires
Listed drug product patent expiration.
Jan 22, 2040
in 13 yr 10 mo
Patent 12029710 expires
Listed method-of-use patent (U-3963) expiration.
Jan 22, 2040
in 13 yr 10 mo

Active ingredient

EPHEDRINE SULFATE

Strength

25MG/5ML (5MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP2

Application

NDA 213994

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
10869845	Jan 22, 2040	in 13 yr 10 mo	Product
12029710	Jan 22, 2040	in 13 yr 10 mo	U-3963