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FDA NDA · NDA021027

HECTOROL

Sponsor: SANOFI

APPLICATION
NDA021027
TYPE
NDA
ORIGINAL APPROVAL
2000-04-06
LATEST ACTION
2022-09-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

HECTOROL · ReferenceDiscontinued
DOXERCALCIFEROL 2MCG/ML (2MCG/ML) · INJECTABLE · INJECTION
HECTOROL · ReferenceDiscontinued
DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) · INJECTABLE · INJECTION

Approval history

2022-09-28Labeling · Supplement 38 · standard — Letter ↗AP
2018-11-21Labeling · Supplement 34 · standard — Label ↗AP
2016-06-01Labeling · Supplement 26 · standard — Label ↗AP
2015-12-15Manufacturing (CMC) · Supplement 31 · standardAP
2014-09-11Manufacturing (CMC) · Supplement 30 · standardAP
2014-07-31Manufacturing (CMC) · Supplement 29 · standardAP
2013-12-24Manufacturing (CMC) · Supplement 28 · standardAP
2013-09-23Manufacturing (CMC) · Supplement 27 · standardAP
2010-12-15Manufacturing (CMC) · Supplement 21AP
2008-12-05Manufacturing (CMC) · Supplement 15 · standard — Letter ↗AP
2006-07-20Labeling · Supplement 13 · standard — Letter ↗AP
2005-06-22Labeling · Supplement 12 · standard — Letter ↗AP
2003-11-26Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2002-11-19Manufacturing (CMC) · Supplement 6 · standardAP
2002-07-24Manufacturing (CMC) · Supplement 5 · standardAP
2002-06-03Manufacturing (CMC) · Supplement 4 · standardAP
2001-06-26Manufacturing (CMC) · Supplement 1 · standardAP
2000-04-06Type 3 - New Dosage Form · Original · standard — Label ↗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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