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FDA NDA · NDA020862

HECTOROL

Sponsor: SANOFI

APPLICATION
NDA020862
TYPE
NDA
ORIGINAL APPROVAL
1999-06-09
LATEST ACTION
2025-06-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

HECTOROL · ReferenceDiscontinued
DOXERCALCIFEROL 2.5MCG · CAPSULE · ORAL
HECTOROL · ReferenceDiscontinued
DOXERCALCIFEROL 0.5MCG · CAPSULE · ORAL
HECTOROL · ReferenceDiscontinued
DOXERCALCIFEROL 1MCG · CAPSULE · ORAL

Approval history

2025-06-11Efficacy · Supplement 33 · standard — Letter ↗AP
2018-11-21Labeling · Supplement 31 · standard — Label ↗AP
2014-01-02Manufacturing (CMC) · Supplement 32 · standardAP
2011-02-11Labeling · Supplement 30 · unknown — Label ↗AP
2009-07-13Manufacturing (CMC) · Supplement 24 — Letter ↗AP
2008-07-10Manufacturing (CMC) · Supplement 23 — Letter ↗AP
2006-07-20Labeling · Supplement 19 · standard — Label ↗AP
2005-06-24Labeling · Supplement 18 · standard — Letter ↗AP
2004-12-17Labeling · Supplement 16 · standard — Letter ↗AP
2004-04-23Efficacy · Supplement 6 · standard — Letter ↗AP
2002-11-19Manufacturing (CMC) · Supplement 10 · standardAP
2002-07-24Manufacturing (CMC) · Supplement 9 · standardAP
2002-06-17Manufacturing (CMC) · Supplement 8 · standardAP
2002-06-03Manufacturing (CMC) · Supplement 7 · standardAP
2001-06-26Manufacturing (CMC) · Supplement 3 · standardAP
2001-06-25Labeling · Supplement 1 · standardAP
2001-05-30Manufacturing (CMC) · Supplement 2 · standardAP
1999-06-09Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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