Approvals and New Uses
The original application and every efficacy supplement, newest first; all 5 submissions below| Date | Submission | Status | Documents |
|---|
| Oct 12, 2001 | Original application | Approved | Letter |
Products
2 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Calcitriol0.25MCG · capsule;oral | Calcitriol | Rx |
| Calcitriol0.5MCG · capsule;oral | Calcitriol | Rx |
All 5 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Jul 24, 2008 | Supplement 4Labeling | Approved | None posted |
| Feb 21, 2007 | Supplement 3Labeling | Approved | None posted |
| Sep 18, 2002 | Supplement 2Labeling | Approved | None posted |
| Apr 16, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Oct 12, 2001 | Original application | Approved | Letter |
Identifiers
- Application
- ANDA 75765
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
