FDA NDA · NDA020169

NILANDRON

Sponsor: ADVANZ PHARMA

APPLICATION

NDA020169

TYPE

NDA

ORIGINAL APPROVAL

1996-09-19

LATEST ACTION

2017-05-17

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

NILANDRON · ReferenceDiscontinued

NILUTAMIDE 150MG · TABLET · ORAL

NILANDRONDiscontinued

NILUTAMIDE 50MG · TABLET · ORAL

2017-05-17Labeling · Supplement 8 · standard — Label ↗AP

2015-09-28Manufacturing (CMC) · Supplement 7 · standardAP

2014-08-13Manufacturing (CMC) · Supplement 6 · standardAP

2004-07-26Labeling · Supplement 3 · standard — Letter ↗AP

2000-09-29Labeling · Supplement 2 · standardAP

1999-04-30Manufacturing (CMC) · Supplement 1 · standardAP

1996-09-19Type 1 - New Molecular Entity · Original · standard — Review ↗AP

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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