SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | A209997 | FRESENIUS KABI USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from C.B. Fleet Company FDA-1978-N-0021 · 41 docket documents C.B. Fleet Company filed this citizen petition on June 25, 2003, requesting that the FDA modify the Tentative Final Monograph on Laxative Drug Products for Over-the-Counter Human Use to include professional labeling for sodium phosphates oral solution (Fleet Phospho-soda) at dosing of 2 x 30 mL to 2 | 505(q) | 2008-12-11 | Denied | C.B. Fleet Company |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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