← FDA DRUG APPROVALS

FDA NDA · NDA020819

ZEMPLAR

paricalcitol

Sponsor: ABBVIE

APPLICATION
NDA020819
TYPE
NDA
ORIGINAL APPROVAL
1998-04-17
LATEST ACTION
2022-10-20
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ZEMPLAR · ReferencePrescription
PARICALCITOL 0.01MG/2ML (0.005MG/ML) · SOLUTION · INTRAVENOUS
ZEMPLAR · ReferencePrescription
PARICALCITOL 0.005MG/ML (0.005MG/ML) · SOLUTION · INTRAVENOUS
ZEMPLAR · ReferencePrescription
PARICALCITOL 0.002MG/ML (0.002MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2022-10-20Labeling · Supplement 38 · standard — Letter ↗AP
2021-05-12Manufacturing (CMC) · Supplement 37 — Letter ↗AP
2021-03-02Labeling · Supplement 36 · standard — Letter ↗AP
2018-11-21Labeling · Supplement 30 · standard — Label ↗AP
2016-11-30Manufacturing (CMC) · Supplement 32 · standardAP
2013-07-22Manufacturing (CMC) · Supplement 31 · standardAP
2011-04-06Labeling · Supplement 25 · unknown — Letter ↗AP
2011-02-01Labeling · Supplement 24 · unknown — Letter ↗AP
2009-08-20Labeling · Supplement 21 · standard — Letter ↗AP
2005-09-02Labeling · Supplement 15 · standard — Label ↗AP
2004-03-31Efficacy · Supplement 14 · priority — Label ↗AP
2003-02-24Labeling · Supplement 11 · standard — Letter ↗AP
2003-02-24Labeling · Supplement 7 · standard — Letter ↗AP
2002-12-06Manufacturing (CMC) · Supplement 12 · standardAP
2002-01-25Manufacturing (CMC) · Supplement 10 · standardAP
2002-01-08Manufacturing (CMC) · Supplement 9 · standardAP
2000-09-13Labeling · Supplement 4 · standardAP
2000-02-02Efficacy · Supplement 3 · unknown — Letter ↗AP
2000-02-01Manufacturing (CMC) · Supplement 6 · standardAP
1999-10-18Manufacturing (CMC) · Supplement 5 · standardAP
1998-04-17Type 1 - New Molecular Entity · 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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