Zemplar

Treats secondary hyperparathyroidism. NDA 20819, held by Abbvie. Paricalcitol.

As of Nov 13, 2026, NDA 20819 (Zemplar), held by Abbvie, was first approved by FDA on Apr 17, 1998, with 20 approved supplements and 0 published complete response letters.

First approved: Apr 17, 1998
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ZEMPLAR is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below


Mar 31, 2004	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 2, 2000	Supplement 3Efficacy (new indication or use)	Approved	Letter Label
Apr 17, 1998	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Written Request

Products

3 strengths and forms


Zemplar0.005MG/ML (0.005MG/ML) · solution;intravenous	Paricalcitol	RxReference drug
Zemplar0.002MG/ML (0.002MG/ML) · solution;intravenous	Paricalcitol	RxReference drug
Zemplar0.01MG/2ML (0.005MG/ML) · solution;intravenous	Paricalcitol	RxReference drug

All 21 submissions, including labeling and manufacturing supplements


Oct 20, 2022	Supplement 38Labeling · Standard review	Approved	Label Letter
May 12, 2021	Supplement 37Manufacturing	Approved	Label Letter
Mar 2, 2021	Supplement 36Labeling · Standard review	Approved	Label Letter
Nov 21, 2018	Supplement 30Labeling · Standard review	Approved	Letter Label
Nov 30, 2016	Supplement 32Manufacturing · Standard review	Approved	None posted
Jul 22, 2013	Supplement 31Manufacturing · Standard review	Approved	None posted
Apr 6, 2011	Supplement 25Labeling	Approved	Letter Label
Feb 1, 2011	Supplement 24Labeling	Approved	Letter
Aug 20, 2009	Supplement 21Labeling · Standard review	Approved	Letter Label
Sep 2, 2005	Supplement 15Labeling · Standard review	Approved	Letter Label
Mar 31, 2004	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 24, 2003	Supplement 11Labeling · Standard review	Approved	Letter
Feb 24, 2003	Supplement 7Labeling · Standard review	Approved	Letter
Dec 6, 2002	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 25, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 8, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 13, 2000	Supplement 4Labeling · Standard review	Approved	None posted
Feb 2, 2000	Supplement 3Efficacy (new indication or use)	Approved	Letter Label
Feb 1, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 18, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 17, 1998	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Written Request

Identifiers

Application: NDA 20819
Drugs@FDA: Overview at FDA
Company: AbbVie

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters