DISOPYRAMIDE PHOSPHATE | N018655 | PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Withdrawal of Approval of 128 Suitability Petitions FDA-1995-P-0005 · 13 docket documents The Food and Drug Administration is withdrawing approval of 128 suitability petitions under the Pediatric Research Equity Act of 2003, a regulatory mechanism that permits abbreviated new drug applications for drugs with different active ingredients, dosage forms, or routes of administration than the | Safety Withdrawal | 2007-03-06 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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