APPLICATION
ANDA086385
TYPE
ANDA
ORIGINAL APPROVAL
1984-01-13
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NANDROLONE DECANOATEDiscontinued
NANDROLONE DECANOATE 50MG/ML · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 28AP
1999-02-02Manufacturing (CMC) · Supplement 27AP
1997-12-08Manufacturing (CMC) · Supplement 26AP
1996-12-04Manufacturing (CMC) · Supplement 25AP
1995-06-29Manufacturing (CMC) · Supplement 24AP
1993-03-04Labeling · Supplement 23AP
1991-02-11Labeling · Supplement 22AP
1989-11-21Labeling · Supplement 21AP
1989-06-21Labeling · Supplement 17AP
1989-03-08Bioequivalence · Supplement 7AP
1989-02-01Manufacturing (CMC) · Supplement 16AP
1989-02-01Manufacturing (CMC) · Supplement 14AP
1989-02-01Manufacturing (CMC) · Supplement 15AP
1988-06-08Labeling · Supplement 12AP
1986-05-02Manufacturing (CMC) · Supplement 10AP
1984-06-07Manufacturing (CMC) · Supplement 8AP
1984-01-13OriginalAP
1984-01-13Manufacturing (CMC) · Supplement 6AP
1983-12-30Manufacturing (CMC) · Supplement 3AP
1983-12-30Manufacturing (CMC) · Supplement 1AP
1983-05-17Manufacturing (CMC) · Supplement 4AP
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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