Zemplar

Treats secondary hyperparathyroidism. NDA 21606, held by Abbvie. Paricalcitol.

As of Nov 14, 2026, NDA 21606 (Zemplar), held by Abbvie, was first approved by FDA on May 26, 2005, with 12 approved supplements and 0 published complete response letters.

First approved: May 26, 2005
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ZEMPLAR is a vitamin D analog indicated in adults and pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with: Chronic kidney disease (CKD) Stages 3 and 4. CKD Stage 5 in patients on hemodialysis or peritoneal dialysis. 1.1 Chronic Kidney Disease Stages 3 and 4

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Oct 18, 2016	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 18, 2016	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 29, 2009	Supplement 4Efficacy (new indication or use)	Approved	Letter Label
May 26, 2005	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

3 strengths and forms


Zemplar1MCG · capsule;oral	Paricalcitol	DiscontinuedReference drug
Zemplar2MCG · capsule;oral	Paricalcitol	DiscontinuedReference drug
Zemplar4MCG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Paricalcitol	DiscontinuedReference drug

All 13 submissions, including labeling and manufacturing supplements


Oct 18, 2016	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 18, 2016	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 18, 2015	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 29, 2014	Supplement 14Labeling · Standard review	Approved	Label Letter
Aug 29, 2014	Supplement 12Labeling · Standard review	Approved	Letter Label
Oct 17, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 28, 2012	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 6, 2011	Supplement 9Labeling	Approved	Letter Letter Label
Jun 11, 2010	Supplement 7Labeling · Standard review	Approved	Letter Label
Jun 29, 2009	Supplement 4Efficacy (new indication or use)	Approved	Letter Label
Jun 18, 2008	Supplement 6Manufacturing	Approved	None posted
Jul 17, 2007	Supplement 5Manufacturing	Approved	None posted
May 26, 2005	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21606
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