BRETYLIUM TOSYLATE | N019005 | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 - "Sterile Bretylium Tosylate 50 mg/mL Injection Package Insert ... FDA-2011-P-0368 I cannot summarize this as a citizen petition because the provided text is only a title reference to a package insert attachment for bretylium tosylate injection, not a complete citizen petition document. To provide an accurate summary identifying the filer, specific action requested, and regulatory | Other | 2011-06-20 | Open | — |
Attachment 1 - "Listing of Bretylium Tosylate 50 mg/mL Injection, Approved Dr... FDA-2011-P-0368 I cannot summarize this petition based on the provided text. The document appears to be only a title and header reference to a listing of approved drug products, without substantive content about who filed a petition, what specific action was requested, or the petition's details. To provide an accur | Other | 2011-06-20 | Open | — |
Attachment 5 - "Discontinued Drug Product List from the Orange Book - Bretyli... FDA-2011-P-0368 The document appears to be a reference list identifying bretylium tosylate injection as a discontinued drug product, including its reference listed drug (RLD) status and associated generic formulations from the Orange Book. However, the content provided does not describe a specific FDA citizen petit | Other | 2011-06-20 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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