Documents
Application Sponsors
| NDA 021214 | SUCAMPO PHARMA LLC | |
Marketing Status
Application Products
| 001 | SOLUTION/DROPS;OPHTHALMIC | 0.15% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | RESCULA | UNOPROSTONE ISOPROPYL |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2000-08-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2012-12-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 7 | AP | 2012-12-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2014-07-10 | PRIORITY |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 0 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 21214
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)