Caverject Impulse

Treats erectile dysfunction. NDA 21212, held by Pfizer. Alprostadil.

As of Nov 15, 2026, NDA 21212 (Caverject Impulse), held by Pfizer, was first approved by FDA on Jun 11, 2002, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 11, 2002
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CAVERJECT IMPULSE is a prostaglandin E1 agonist indicated

For the treatment of erectile dysfunction
As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction. 1.1 Erectile Dysfunction CAVERJECT IMPULSE is indicated for the treatment of erectile dysfunction. 1.2 Diagnostic Test CAVERJECT IMPULSE is indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jun 11, 2002	Original applicationNew dosage form · Standard review	Approved	Letter Review Label

Products

2 strengths and forms


Caverject Impulse0.01MG/VIAL · injectable;injection	Alprostadil	Rx
Caverject Impulse0.02MG/VIAL · injectable;injection	Alprostadil	Rx

All 11 submissions, including labeling and manufacturing supplements


Dec 23, 2022	Supplement 18Labeling · Standard review	Approved	Label Letter
Dec 1, 2016	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 25, 2016	Supplement 15Labeling · Standard review	Approved	Label Letter
Oct 25, 2016	Supplement 16Labeling · Standard review	Approved	Label Letter
May 5, 2016	Supplement 14Labeling · Standard review	Approved	Letter Label
Oct 27, 2015	Supplement 11Labeling · Standard review	Approved	Label Letter
Jan 12, 2015	Supplement 12Manufacturing · Standard review	Approved	None posted
Jun 11, 2014	Supplement 10Labeling · Standard review	Approved	Letter
Dec 19, 2013	Supplement 7Labeling · Standard review	Approved	Label Letter
Sep 2, 2003	Supplement 2Labeling · Standard review	Approved	Letter
Jun 11, 2002	Original applicationNew dosage form · Standard review	Approved	Letter Review Label

Identifiers

Application: NDA 21212
Drugs@FDA: Overview at FDA
Company: Pfizer

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