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FDA NDA · NDA016848

ANADROL-50

Sponsor: PHARMOBEDIENT

APPLICATION
NDA016848
TYPE
NDA
ORIGINAL APPROVAL
1972-01-18
LATEST ACTION
2014-02-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ANADROL-50 · ReferenceDiscontinued
OXYMETHOLONE 50MG · TABLET · ORAL

Approval history

2014-02-06Manufacturing (CMC) · Supplement 23 · standardAP
2004-08-25Labeling · Supplement 21 · standard — Letter ↗AP
2003-11-17Labeling · Supplement 20 · standard — Letter ↗AP
2002-02-06Manufacturing (CMC) · Supplement 19 · standardAP
1997-05-14Manufacturing (CMC) · Supplement 18 · standardAP
1994-06-09Manufacturing (CMC) · Supplement 17 · standardAP
1993-07-15Labeling · Supplement 16AP
1993-07-15Labeling · Supplement 13AP
1992-08-24Manufacturing (CMC) · Supplement 14 · standardAP
1992-02-18Labeling · Supplement 15AP
1991-08-14Labeling · Supplement 12AP
1990-01-26Manufacturing (CMC) · Supplement 11 · standardAP
1986-08-25Labeling · Supplement 10AP
1983-01-18Manufacturing (CMC) · Supplement 9 · standardAP
1980-04-15Labeling · Supplement 6AP
1976-06-15Manufacturing (CMC) · Supplement 5 · standardAP
1975-10-10Manufacturing (CMC) · Supplement 4 · standardAP
1972-01-18Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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