MIRTAZAPINE | N021208 | ORGANON USA LLC A SUB OF ORGANON AND CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from AAC Consulting Group FDA-2002-P-0471 · 4 docket documents AAC Consulting Group filed this citizen petition on May 29, 2002, requesting that the FDA determine that 7.5 mg tablets of mirtazapine are suitable for an Abbreviated New Drug Application (ANDA) based on the listed drug Remeron 8 Tablets, 15 mg. The petitioner argued that the proposed generic produc | Other | 2023-10-27 | Granted | AAC Consulting Group |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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