Documents
Application Sponsors
Marketing Status
Application Products
| 001 | SOLUTION;ORAL | 100MG/ML | 1 | SANDIMMUNE | CYCLOSPORINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1983-11-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1993-02-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1993-02-24 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1991-03-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 6 | AP | 1991-06-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1992-02-21 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1993-02-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1993-03-19 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1994-05-09 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1994-05-09 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1994-05-19 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1995-03-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 15 | AP | 1994-11-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1995-04-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 17 | AP | 1995-11-21 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 1996-08-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1996-03-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1998-03-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1998-01-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1998-07-27 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1998-10-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1999-05-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 25 | AP | 2000-10-04 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 1999-12-21 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2003-02-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2001-11-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 29 | AP | 2003-02-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2002-02-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2002-01-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2002-06-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2002-04-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 35 | AP | 2004-02-06 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2004-02-06 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2005-07-19 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2006-03-06 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2009-10-08 | UNKNOWN |
| LABELING; Labeling | SUPPL | 42 | AP | 2010-04-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 43 | AP | 2012-08-30 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2013-05-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 2014-01-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 51 | AP | 2015-03-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 2016-07-14 | PRIORITY |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | 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 | 24 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 41 | Null | 6 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 43 | Null | 6 |
| SUPPL | 47 | Null | 7 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 51 | Null | 15 |
| SUPPL | 52 | Null | 0 |
TE Codes
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 50574
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)