APPLICATION
NDA010753
TYPE
NDA
ORIGINAL APPROVAL
1957-04-17
LATEST ACTION
1990-09-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ESTRADURINDiscontinued
POLYESTRADIOL PHOSPHATE 40MG/AMP · INJECTABLE · INJECTION
Approval history
1990-09-06Manufacturing (CMC) · Supplement 20 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 19 · standardAP
1989-04-14Manufacturing (CMC) · Supplement 18 · standardAP
1985-02-19Manufacturing (CMC) · Supplement 15 · standardAP
1981-09-01Efficacy · Supplement 12 · standardAP
1981-06-15Efficacy · Supplement 11 · standardAP
1979-12-13Efficacy · Supplement 8 · standardAP
1979-12-13Efficacy · Supplement 10 · standardAP
1979-12-13Efficacy · Supplement 9 · standardAP
1957-04-17Type 1 - New Molecular Entity · Original · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.