APPLICATION
NDA020649
TYPE
NDA
ORIGINAL APPROVAL
1997-06-12
LATEST ACTION
2016-11-17
ROUTE
INTRACAVERNOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
EDEX · ReferencePrescription
ALPROSTADIL 0.01MG/VIAL · INJECTABLE · INJECTION
EDEX · ReferencePrescription
ALPROSTADIL 0.02MG/VIAL · INJECTABLE · INJECTION
EDEXDiscontinued
ALPROSTADIL 0.005MG/VIAL · INJECTABLE · INJECTION
EDEX · ReferencePrescription
ALPROSTADIL 0.02MG/VIAL · INJECTABLE · INJECTION
EDEX · ReferencePrescription
ALPROSTADIL 0.04MG/VIAL · INJECTABLE · INJECTION
EDEX · ReferencePrescription
ALPROSTADIL 0.01MG/VIAL · INJECTABLE · INJECTION
EDEX · ReferencePrescription
ALPROSTADIL 0.04MG/VIAL · INJECTABLE · INJECTION
Approval history
2016-11-17Manufacturing (CMC) · Supplement 24 · standardAP
2014-03-12Manufacturing (CMC) · Supplement 22 · standardAP
2014-02-11Manufacturing (CMC) · Supplement 21 · standardAP
2001-12-14Manufacturing (CMC) · Supplement 13 · standardAP
2000-07-31Manufacturing (CMC) · Supplement 11 · standardAP
2000-06-01Manufacturing (CMC) · Supplement 12 · standardAP
2000-03-10Manufacturing (CMC) · Supplement 10 · standardAP
1999-11-19Manufacturing (CMC) · Supplement 6 · standardAP
1999-10-20Manufacturing (CMC) · Supplement 7 · standardAP
1999-10-20Manufacturing (CMC) · Supplement 5 · standardAP
1999-10-15Manufacturing (CMC) · Supplement 8 · standardAP
1999-09-06Labeling · Supplement 9 · standardAP
1998-09-22Manufacturing (CMC) · Supplement 4 · standardAP
1998-07-30Manufacturing (CMC) · Supplement 2 · standardAP
1998-04-01Manufacturing (CMC) · Supplement 3 · standardAP
1997-11-05Manufacturing (CMC) · Supplement 1 · standardAP
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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