NDA 18874, held by Abbvie. Calcitriol.
As of Nov 13, 2026, NDA 18874 (Calcijex), held by Abbvie, was first approved by FDA on Sep 25, 1986, with 16 approved supplements and 0 published complete response letters.
| Nov 16, 2001 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Oct 22, 1996 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 25, 1986 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Calcijex0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Calcitriol | DiscontinuedReference drug |
| Calcijex0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Calcitriol | DiscontinuedReference drug |
| Mar 9, 2012 | Supplement 22Labeling · Standard review | Approved | |
| Jul 1, 2007 | Supplement 19Labeling · Standard review | Approved | |
| Nov 16, 2001 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| May 7, 2001 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jan 29, 2001 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Sep 15, 2000 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Apr 4, 2000 | Supplement 10Labeling · Standard review | Approved | None posted |
| Dec 2, 1999 | Supplement 12Labeling · Standard review | Approved | None posted |
| May 26, 1999 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Dec 31, 1997 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jun 10, 1997 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 22, 1996 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jan 5, 1996 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Oct 31, 1995 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1991 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Apr 4, 1990 | Supplement 2Labeling | Approved | None posted |
| Sep 25, 1986 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
