CALCITONIN SALMON | N017808 | MYLAN IRELAND LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Meridian Consulting LLC on behalf of MAIVA PHARMA PVT LTD FDA-2022-P-2517 · 5 docket documents Maiva Pharma Private Limited, filed through Meridian Consulting LLC, submitted a citizen petition requesting that the FDA determine whether Miacalcin (calcitonin salmon, USP) Injection, 100 USP Units/mL, approved under NDA 017808 and held by Mylan Ireland Limited, was voluntarily withdrawn for reaso | 505(q) | 2022-10-13 | Granted | MAIVA PHARMA PVT LTD |
Citizen Petition from Foley & Lardner LLP FDA-2005-P-0367 · 6 docket documents Foley & Lardner LLP filed this citizen petition requesting that the FDA not approve any abbreviated new drug applications or new drug applications under section 505(b)(2) for salmon calcitonin nasal spray products citing Miacalcin as the reference listed drug unless applicants demonstrate that the a | 505(q) | 2008-11-18 | Partially Denied | Foley & Lardner LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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