Application 021406
- Type
- NDA
- Sponsor
- UPSHER SMITH LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FORTICAL | CALCITONIN SALMON RECOMBINANT | SPRAY, METERED;NASAL | 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0245-0008 | Fortical | calcitonin salmon | Upsher-Smith Laboratories, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 36824 | SUPPL | 2014-07-11 |
| 27680 | SUPPL | 2014-07-10 |
| 5260 | SUPPL | 2014-07-10 |
| 27679 | SUPPL | 2011-08-17 |
| 15376 | SUPPL | 2011-08-16 |
| 27678 | SUPPL | 2009-06-26 |
| 15375 | SUPPL | 2009-06-24 |
| 21638 | ORIG | 2007-05-09 |
| 5259 | SUPPL | 2007-02-12 |
| 36823 | SUPPL | 2006-05-01 |
| 27677 | SUPPL | 2006-05-01 |
| 27676 | ORIG | 2005-08-19 |
| 15374 | ORIG | 2005-08-15 |