← FDA DRUG APPROVALS

FDA NDA · NDA021606

ZEMPLAR

paricalcitol

Sponsor: ABBVIE

APPLICATION
NDA021606
TYPE
NDA
ORIGINAL APPROVAL
2005-05-26
LATEST ACTION
2016-10-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ZEMPLAR · ReferenceDiscontinued
PARICALCITOL 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
ZEMPLAR · ReferenceDiscontinued
PARICALCITOL 1MCG · CAPSULE · ORAL
ZEMPLAR · ReferenceDiscontinued
PARICALCITOL 2MCG · CAPSULE · ORAL

Approval history

2016-10-18Efficacy · Supplement 17 · standard — Letter ↗AP
2016-10-18Efficacy · Supplement 16 · standard — Letter ↗AP
2015-08-18Manufacturing (CMC) · Supplement 15 · standardAP
2014-08-29Labeling · Supplement 12 · standard — Label ↗AP
2014-08-29Labeling · Supplement 14 · standard — Label ↗AP
2013-10-17Manufacturing (CMC) · Supplement 13 · standardAP
2012-06-28Manufacturing (CMC) · Supplement 10 · standardAP
2011-04-06Labeling · Supplement 9 · unknown — Letter ↗AP
2010-06-11Labeling · Supplement 7 · standard — Letter ↗AP
2009-06-29Efficacy · Supplement 4 · unknown — Letter ↗AP
2008-06-18Manufacturing (CMC) · Supplement 6AP
2007-07-17Manufacturing (CMC) · Supplement 5AP
2005-05-26Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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