Orange Book product · Brand (NDA)

IMMPHENTIV

PHENYLEPHRINE HYDROCHLORIDE

Brand (NDA)NDA 203826RX HIKMA

Mar 09, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 09, 2023
3 yr 4 mo ago
Today
Patent 11471400 expires
Listed drug product patent expiration.
Aug 05, 2036
in 10 yr 3 mo
Patent 11213480 expires
Listed drug product patent expiration.
Sep 26, 2036
in 10 yr 5 mo
Patent 12257342 expires
Listed drug product patent expiration.
Sep 26, 2036
in 10 yr 5 mo

Active ingredient

PHENYLEPHRINE HYDROCHLORIDE

Strength

0.5MG/5ML (0.1MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 203826

Product number

004

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
11471400	Aug 05, 2036	in 10 yr 3 mo	Product
11213480	Sep 26, 2036	in 10 yr 5 mo	Product
12257342	Sep 26, 2036	in 10 yr 5 mo	Product