APPLICATION
ANDA085620
TYPE
ANDA
ORIGINAL APPROVAL
1981-11-02
LATEST ACTION
2024-02-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ESTRADIOL CYPIONATEDiscontinued
ESTRADIOL CYPIONATE 5MG/ML · INJECTABLE · INJECTION
Approval history
2024-02-16Labeling · Supplement 20 · standardAP
1999-02-19Manufacturing (CMC) · Supplement 18AP
1999-02-02Manufacturing (CMC) · Supplement 17AP
1998-03-17Manufacturing (CMC) · Supplement 16AP
1996-12-04Manufacturing (CMC) · Supplement 15AP
1996-08-20Labeling · Supplement 14AP
1991-07-01Labeling · Supplement 13AP
1990-12-12Labeling · Supplement 21AP
1990-12-12Labeling · Supplement 12AP
1988-10-05Manufacturing (CMC) · Supplement 11AP
1988-10-05Manufacturing (CMC) · Supplement 10AP
1988-10-05Manufacturing (CMC) · Supplement 9AP
1986-05-01Manufacturing (CMC) · Supplement 3AP
1983-12-22Manufacturing (CMC) · Supplement 1AP
1981-11-02OriginalAP
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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