APPLICATION
ANDA088128
TYPE
ANDA
ORIGINAL APPROVAL
1983-12-05
LATEST ACTION
2002-06-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NANDROLONE DECANOATE · ReferenceDiscontinued
NANDROLONE DECANOATE 200MG/ML · INJECTABLE · INJECTION
Approval history
2002-06-17Manufacturing (CMC) · Supplement 19AP
2002-06-17Manufacturing (CMC) · Supplement 17AP
2002-06-17Manufacturing (CMC) · Supplement 18AP
1999-02-19Manufacturing (CMC) · Supplement 15AP
1999-02-02Manufacturing (CMC) · Supplement 14AP
1997-12-08Manufacturing (CMC) · Supplement 13AP
1996-12-04Manufacturing (CMC) · Supplement 12AP
1995-07-19Manufacturing (CMC) · Supplement 11AP
1993-03-04Labeling · Supplement 10AP
1991-02-11Labeling · Supplement 9AP
1989-11-21Labeling · Supplement 8AP
1989-08-04Labeling · Supplement 7AP
1988-12-13Bioequivalence · Supplement 6AP
1988-12-05Manufacturing (CMC) · Supplement 4AP
1988-12-05Manufacturing (CMC) · Supplement 5AP
1986-04-30Manufacturing (CMC) · Supplement 2AP
1984-06-07Manufacturing (CMC) · Supplement 1AP
1983-12-05OriginalAP
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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