APPLICATION
ANDA085470
TYPE
ANDA
ORIGINAL APPROVAL
1979-08-15
LATEST ACTION
2024-02-21
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
DEPO-ESTRADIOLDiscontinued
ESTRADIOL CYPIONATE 3MG/ML · INJECTABLE · INJECTION
DEPO-ESTRADIOLPrescription
ESTRADIOL CYPIONATE 5MG/ML · INJECTABLE · INJECTION
DEPO-ESTRADIOLDiscontinued
ESTRADIOL CYPIONATE 1MG/ML · INJECTABLE · INJECTION
Approval history
2024-02-21Labeling · Supplement 27 · standardAP
2019-05-03Labeling · Supplement 23 · standardAP
2002-05-28Manufacturing (CMC) · Supplement 13AP
2000-04-05Manufacturing (CMC) · Supplement 12AP
1998-06-01Labeling · Supplement 10AP
1982-07-01Manufacturing (CMC) · Supplement 3AP
1982-07-01Manufacturing (CMC) · Supplement 4AP
1979-08-15OriginalAP
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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