APPLICATION
NDA009165
TYPE
NDA
ORIGINAL APPROVAL
1953-12-24
LATEST ACTION
2016-10-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DELATESTRYLDiscontinued
TESTOSTERONE ENANTHATE 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
DELATESTRYL · ReferenceDiscontinued
TESTOSTERONE ENANTHATE 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2002-06-06Manufacturing (CMC) · Supplement 28 · priorityAP
1999-12-14Manufacturing (CMC) · Supplement 27 · priorityAP
1997-12-31Manufacturing (CMC) · Supplement 26 · priorityAP
1991-12-09Labeling · Supplement 25AP
1989-05-05Manufacturing (CMC) · Supplement 24 · priorityAP
1987-09-01Labeling · Supplement 22AP
1987-09-01Manufacturing (CMC) · Supplement 21 · priorityAP
1987-02-10Manufacturing (CMC) · Supplement 19 · priorityAP
1986-05-05Manufacturing (CMC) · Supplement 20 · priorityAP
1985-07-31Manufacturing (CMC) · Supplement 18 · priorityAP
1984-01-31Labeling · Supplement 16AP
1980-02-01Efficacy · Supplement 14AP
1980-02-01Efficacy · Supplement 15AP
1979-08-02Efficacy · Supplement 9AP
1977-07-15Labeling · Supplement 6AP
1953-12-24Type 2 - New Active Ingredient · Original · priorityAP
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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