Phenylephrine Hydrochloride, Immphentiv

For clinically important hypotension resulting primarily from vasodilation. NDA 203826, held by Hikma. Phenylephrine Hydrochloride.

As of Nov 14, 2026, NDA 203826 (Phenylephrine Hydrochloride, Immphentiv), held by Hikma, was first approved by FDA on Dec 20, 2012, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 20, 2012
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Phenylephrine Hydrochloride is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Dec 20, 2012	Original applicationTYPE 7 · Standard review	Approved	Review Summary Review Letter Label

Products

5 strengths and forms


Phenylephrine Hydrochloride10MG/ML (10MG/ML) · solution;intravenous	Phenylephrine Hydrochloride	RxReference drug
Phenylephrine Hydrochloride50MG/5ML (10MG/ML) · solution;intravenous	Phenylephrine Hydrochloride	RxReference drug
Phenylephrine Hydrochloride100MG/10ML (10MG/ML) · solution;intravenous	Phenylephrine Hydrochloride	RxReference drug
Immphentiv0.5MG/5ML (0.1MG/ML) · solution;intravenous	Phenylephrine Hydrochloride	RxReference drug
Immphentiv1MG/10ML (0.1MG/ML) · solution;intravenous	Phenylephrine Hydrochloride	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Mar 9, 2023	Supplement 15Manufacturing	Approved	Label Letter
Mar 9, 2023	Supplement 17Labeling · Standard review	Approved	Label Letter
Jun 19, 2019	Supplement 9Manufacturing · Standard review	Approved	Label
Dec 9, 2016	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 6, 2016	Supplement 2Labeling · Standard review	Approved	Label Letter
Feb 16, 2015	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 23, 2014	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 20, 2012	Original applicationTYPE 7 · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 203826
Drugs@FDA: Overview at FDA
Company: Hikma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters