OCTREOTIDE ACETATE | N208232 | CHIESI FARMACEUTICI SPA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Rakoczy Molino Mazzochi Siwik LLP FDA-2006-P-0331 · 6 docket documents Ben Venue Laboratories, Inc. and Sun Pharmaceuticals Industries Ltd. filed citizen petitions requesting that the FDA determine whether the discontinued formulation of Sandostatin (octreotide acetate injection) was withdrawn for reasons of safety or effectiveness under NDA 19-667, which the FDA grant | Other | 2009-04-20 | Partially Denied | Rakoczy Molino Mazzochi Siwik LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8329198 | Sep 17, 2029 | — | — | Yes | — | — |
| 8535695 | Sep 17, 2029 | — | — | — | — | |
| 9265812 | Sep 17, 2029 | — | — | Yes | — | — |
| 9566246 | Sep 17, 2029 | — | — | Yes | — | — |
| 10238709 | Feb 3, 2036 | — | — | — | — | |
| 10695397 | Feb 3, 2036 | — | — | — | — | |
| 11052126 | Feb 3, 2036 | — | — | — | — | |
| 11141457 | Dec 28, 2040 | — | — | — | — | |
| 11338011 | Feb 3, 2036 | — | — | — | — | |
| 11510963 | Feb 3, 2036 | — | — | — | — | |
| 11857595 | Feb 3, 2036 | — | — | — | — | |
| 11890316 | Dec 28, 2040 | — | — | — | — | |
| 11969471 | Sep 17, 2029 | — | — | Yes | — | — |
| 11986529 | Sep 17, 2029 | — | — | — | — | |
| 12246054 | Feb 3, 2036 | — | — | — | — | |
| 12251418 | Feb 3, 2036 | — | — | — | — |
| Code | Date | Status |
|---|---|---|
| ODE-474 | Jun 26, 2027 | < 1 year |