Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 0.25MCG | 1 | ROCALTROL | CALCITRIOL |
| 002 | CAPSULE;ORAL | 0.5MCG | 1 | ROCALTROL | CALCITRIOL |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1978-08-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1979-11-09 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 1982-04-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1980-05-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1980-12-10 | PRIORITY |
| LABELING; Labeling | SUPPL | 8 | AP | 1982-04-22 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1983-11-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1986-09-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1984-08-20 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 1986-01-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1985-12-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 15 | AP | 1986-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1988-04-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 17 | AP | 1988-04-27 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1991-04-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1990-03-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1991-09-24 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1993-09-24 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1995-12-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1995-05-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 24 | AP | 1996-10-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 1998-11-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1999-04-27 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2000-12-15 | PRIORITY |
| LABELING; Labeling | SUPPL | 28 | AP | 2002-02-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2001-10-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2001-11-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 32 | AP | 2004-07-07 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2010-02-22 | UNKNOWN |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 38 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 18044
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)