APPLICATION
NDA017968
TYPE
NDA
ORIGINAL APPROVAL
1980-06-13
LATEST ACTION
2002-05-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEPO-TESTADIOLDiscontinued
ESTRADIOL CYPIONATE 2MG/ML, TESTOSTERONE CYPIONATE 50MG/ML · INJECTABLE · INJECTION
Approval history
2002-05-23Manufacturing (CMC) · Supplement 9 · standardAP
2000-04-03Manufacturing (CMC) · Supplement 8 · standardAP
1996-02-22Labeling · Supplement 6 · standardAP
1994-07-15Labeling · Supplement 7 · standardAP
1993-05-10Labeling · Supplement 5 · standardAP
1985-06-28Labeling · Supplement 3 · standardAP
1982-04-15Manufacturing (CMC) · Supplement 2 · standardAP
1980-06-13Type 5 - New Formulation or New Manufacturer · 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.
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