Vasostrict

For vasodilatory shock. NDA 204485, held by Ph Health. Vasopressin.

As of Nov 14, 2026, NDA 204485 (Vasostrict), held by Ph Health, was first approved by FDA on Apr 17, 2014, with 14 approved supplements and 0 published complete response letters.

First approved: Apr 17, 2014
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Vasostrict is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Apr 17, 2014	Original applicationTYPE 7 · Standard review	Approved	Review Summary Review Label Letter

Products

6 strengths and forms


Vasostrict20UNITS/ML (20UNITS/ML) · solution;intravenous	Vasopressin	RxReference drug
Vasostrict200UNITS/10ML (20UNITS/ML) · solution;intravenous	Vasopressin	RxReference drug
Vasostrict40UNITS/100ML (0.4UNITS/ML) · solution;intravenous	Vasopressin	RxReference drug
Vasostrict60UNITS/100ML (0.6UNITS/ML) · solution;intravenous	Vasopressin	DiscontinuedReference drug
Vasostrict20UNITS/100ML (0.2UNITS/ML) · solution;intravenous	Vasopressin	RxReference drug
Vasostrict50UNITS/50ML (1UNITS/ML) · solution;intravenous	Vasopressin	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Apr 12, 2023	Supplement 30Manufacturing	Approved	Label Letter
Dec 6, 2022	Supplement 27Labeling · Standard review	Approved	Label Letter
Nov 22, 2022	Supplement 26Labeling · Standard review	Approved	Label Letter
Sep 14, 2022	Supplement 25Labeling · Standard review	Approved	Letter Label
Apr 21, 2021	Supplement 20Manufacturing	Approved	Review Letter Label
Mar 26, 2021	Supplement 11Labeling · Standard review	Approved	Letter Label
Mar 15, 2021	Supplement 17Labeling · Standard review	Approved	Label Letter
Apr 15, 2020	Supplement 13Manufacturing · Standard review	Approved	Review Label Letter
Feb 21, 2020	Supplement 14Labeling · Standard review	Approved	Label Letter
May 14, 2019	Supplement 9Labeling · Standard review	Approved	Label Letter
Dec 17, 2016	Supplement 4Manufacturing · Standard review	Approved	Review Label
Mar 21, 2016	Supplement 3Manufacturing · Standard review	Approved	Review Label
May 7, 2015	Supplement 2Manufacturing · Standard review	Approved	Letter Label
Sep 18, 2014	Supplement 1Manufacturing · Standard review	Approved	Label
Apr 17, 2014	Original applicationTYPE 7 · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 204485
Drugs@FDA: Overview at FDA
Company: PH Health

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