OCTREOTIDE ACETATE | N019667 | NOVARTIS PHARMACEUTICALS CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Caplin Steriles Limited FDA-2021-P-0163 · 4 docket documents Caplin Steriles Limited filed this citizen petition on February 5, 2021, requesting that the FDA determine whether Sandostatin (octreotide acetate injection, 0.2 mg and 1 mg strengths) under NDA 019667 held by Novartis Pharmaceuticals was withdrawn from sale for safety or effectiveness reasons. The | 505(q) | 2021-02-05 | Denied | Caplin Steriles Limited |
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that the FDA determine whether the discontinued formulation of Sandostatin (octreotide acetate injection) was withdrawn for reasons of safety or effectiveness under NDA 19-667, which the FDA grant | Other | 2009-04-20 | Partially Denied | Rakoczy Molino Mazzochi Siwik LLP |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.
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