APPLICATION
NDA011891
TYPE
NDA
ORIGINAL APPROVAL
1959-10-30
LATEST ACTION
1994-02-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DURABOLINDiscontinued
NANDROLONE PHENPROPIONATE 25MG/ML · INJECTABLE · INJECTION
DURABOLINDiscontinued
NANDROLONE PHENPROPIONATE 50MG/ML · INJECTABLE · INJECTION
Approval history
1994-02-18Manufacturing (CMC) · Supplement 16 · standardAP
1990-05-08Manufacturing (CMC) · Supplement 15 · standardAP
1987-08-20Labeling · Supplement 13AP
1987-03-25Manufacturing (CMC) · Supplement 14 · standardAP
1987-01-07Manufacturing (CMC) · Supplement 11 · standardAP
1985-11-19Labeling · Supplement 10AP
1959-10-30Type 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.
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