APPLICATION
NDA020379
TYPE
NDA
ORIGINAL APPROVAL
1995-07-06
LATEST ACTION
2022-12-23
ROUTE
INTRACAVERNOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
CAVERJECT · ReferencePrescription
ALPROSTADIL 0.04MG/VIAL · INJECTABLE · INJECTION
CAVERJECT · ReferencePrescription
ALPROSTADIL 0.02MG/VIAL · INJECTABLE · INJECTION
CAVERJECT · ReferenceDiscontinued
ALPROSTADIL 0.005MG/VIAL · INJECTABLE · INJECTION
CAVERJECT · ReferencePrescription
ALPROSTADIL 0.01MG/VIAL · INJECTABLE · INJECTION
Approval history
2016-02-08Manufacturing (CMC) · Supplement 21 · priorityAP
2014-06-09Manufacturing (CMC) · Supplement 27 · priorityAP
2014-03-28Manufacturing (CMC) · Supplement 26 · priorityAP
2002-10-15Manufacturing (CMC) · Supplement 16 · priorityAP
2001-03-29Manufacturing (CMC) · Supplement 15 · priorityAP
2000-11-29Manufacturing (CMC) · Supplement 13 · priorityAP
2000-04-03Manufacturing (CMC) · Supplement 14 · priorityAP
1999-07-02Labeling · Supplement 12 · standardAP
1999-01-20Labeling · Supplement 10 · standardAP
1998-05-20Manufacturing (CMC) · Supplement 8 · priorityAP
1997-10-08Labeling · Supplement 6 · standardAP
1997-05-19Manufacturing (CMC) · Supplement 7 · priorityAP
1996-10-21Labeling · Supplement 5 · standardAP
1996-06-28Labeling · Supplement 4 · standardAP
1996-06-27Manufacturing (CMC) · Supplement 3 · priorityAP
1996-05-13Manufacturing (CMC) · Supplement 2 · priorityAP
1996-03-19Manufacturing (CMC) · Supplement 1 · priorityAP
1995-07-06Type 3 - New Dosage Form · Original · priorityAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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