HYDRALAZINE HYDROCHLORIDE | A040373 | TEVA PARENTERAL MEDICINES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Withdrawal of Approval of 128 Suitability Petitions FDA-1986-P-0498 The FDA is withdrawing approval of 128 suitability petitions that had been approved before the Pediatric Research Equity Act of 2003 took effect, because no abbreviated new drug applications were ever submitted under these petitions and any future applications would now be required to include pediat | Safety Withdrawal | 2007-03-01 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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