Caverject

Treats erectile dysfunction. NDA 20379, held by Pfizer. Alprostadil.

As of Nov 13, 2026, NDA 20379 (Caverject), held by Pfizer, was first approved by FDA on Jul 6, 1995, with 26 approved supplements and 0 published complete response letters.

First approved: Jul 6, 1995
Review: Priority
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CAVERJECT 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 is indicated for the treatment of erectile dysfunction. 1.2 Diagnostic Test CAVERJECT 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 27 submissions below

Date	Submission	Status	Documents
Jul 6, 1995	Original applicationNew dosage form · Priority review	Approved	None posted

Products

4 strengths and forms


Caverject0.01MG/VIAL · injectable;injection	Alprostadil	RxReference drug
Caverject0.02MG/VIAL · injectable;injection	Alprostadil	RxReference drug
Caverject0.005MG/VIAL · injectable;injection	Alprostadil	DiscontinuedReference drug
Caverject0.04MG/VIAL · injectable;injection	Alprostadil	RxReference drug

All 27 submissions, including labeling and manufacturing supplements


Dec 23, 2022	Supplement 38Labeling · Standard review	Approved	Label Letter
Dec 6, 2017	Supplement 34Labeling · Standard review	Approved	Letter Label
Dec 6, 2017	Supplement 32Labeling · Standard review	Approved	Letter Label
Dec 6, 2017	Supplement 31Labeling · Standard review	Approved	Letter Label
May 5, 2016	Supplement 30Labeling · Standard review	Approved	Letter Label
Feb 8, 2016	Supplement 21Manufacturing · Priority review	Approved	None posted
Jun 12, 2014	Supplement 28Labeling · Standard review	Approved	Letter Label
Jun 9, 2014	Supplement 27Manufacturing · Priority review	Approved	None posted
Mar 28, 2014	Supplement 26Manufacturing · Priority review	Approved	None posted
Sep 2, 2003	Supplement 17Labeling · Standard review	Approved	Letter
Oct 15, 2002	Supplement 16Manufacturing · Priority review	Approved	None posted
Jan 15, 2002	Supplement 11Labeling · Standard review	Approved	Letter
Mar 29, 2001	Supplement 15Manufacturing · Priority review	Approved	None posted
Nov 29, 2000	Supplement 13Manufacturing · Priority review	Approved	None posted
Apr 3, 2000	Supplement 14Manufacturing · Priority review	Approved	None posted
Jul 2, 1999	Supplement 12Labeling · Standard review	Approved	None posted
Jan 20, 1999	Supplement 10Labeling · Standard review	Approved	None posted
May 20, 1998	Supplement 8Manufacturing · Priority review	Approved	None posted
Mar 26, 1998	Supplement 9Labeling · Standard review	Approved	Review
Oct 8, 1997	Supplement 6Labeling · Standard review	Approved	None posted
May 19, 1997	Supplement 7Manufacturing · Priority review	Approved	None posted
Oct 21, 1996	Supplement 5Labeling · Standard review	Approved	None posted
Jun 28, 1996	Supplement 4Labeling · Standard review	Approved	None posted
Jun 27, 1996	Supplement 3Manufacturing · Priority review	Approved	None posted
May 13, 1996	Supplement 2Manufacturing · Priority review	Approved	None posted
Mar 19, 1996	Supplement 1Manufacturing · Priority review	Approved	None posted
Jul 6, 1995	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 20379
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