APPLICATION
ANDA086598
TYPE
ANDA
ORIGINAL APPROVAL
1984-01-13
LATEST ACTION
2002-06-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NANDROLONE DECANOATEDiscontinued
NANDROLONE DECANOATE 100MG/ML · INJECTABLE · INJECTION
Approval history
2002-06-17Manufacturing (CMC) · Supplement 26AP
2002-06-17Manufacturing (CMC) · Supplement 27AP
2002-06-17Manufacturing (CMC) · Supplement 25AP
1999-02-19Manufacturing (CMC) · Supplement 23AP
1999-02-02Manufacturing (CMC) · Supplement 22AP
1997-12-08Manufacturing (CMC) · Supplement 21AP
1995-06-29Manufacturing (CMC) · Supplement 20AP
1991-02-11Labeling · Supplement 18AP
1989-11-21Labeling · Supplement 17AP
1989-07-19Manufacturing (CMC) · Supplement 15AP
1989-06-21Labeling · Supplement 16AP
1988-09-23Bioequivalence · Supplement 12AP
1988-08-02Manufacturing (CMC) · Supplement 14AP
1988-08-02Manufacturing (CMC) · Supplement 13AP
1988-06-08Labeling · Supplement 11AP
1986-05-02Manufacturing (CMC) · Supplement 9AP
1984-06-07Manufacturing (CMC) · Supplement 8AP
1984-01-13Manufacturing (CMC) · Supplement 6AP
1984-01-13OriginalAP
1983-12-29Manufacturing (CMC) · Supplement 1AP
1983-12-29Manufacturing (CMC) · Supplement 2AP
1983-05-17Manufacturing (CMC) · Supplement 5AP
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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