Application 021214
- Type
- NDA
- Sponsor
- SUCAMPO PHARMA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RESCULA | UNOPROSTONE ISOPROPYL | SOLUTION/DROPS;OPHTHALMIC | 0.15% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 21513 | SUPPL | 2015-11-18 |
| 21514 | SUPPL | 2015-11-17 |
| 36367 | SUPPL | 2012-12-10 |
| 14643 | SUPPL | 2012-12-10 |
| 21512 | ORIG | 2004-06-16 |
| 36366 | ORIG | 2000-08-03 |
| 27083 | ORIG | 2000-08-03 |