ACETAMINOPHEN AND CODEINE PHOSPHATE

FDA-1993-P-0062

The FDA withdrew approval of 128 suitability petitions in this notice, as required by the Pediatric Research Equity Act of 2003. These petitions had previously permitted abbreviated new drug applications for drugs with different active ingredients, dosage forms, or routes of administration from thei

FDA-1995-P-0011

The FDA is withdrawing approval of 128 suitability petitions filed by various pharmaceutical manufacturers, as these petitions no longer satisfy regulatory requirements under the Pediatric Research Equity Act of 2003. The withdrawn petitions had previously approved ANDAs for drugs with different act

FDA-1984-P-0015

The Food and Drug Administration is withdrawing approval of 128 suitability petitions because no abbreviated new drug applications were submitted for these drugs prior to April 1, 1999, and the Pediatric Research Equity Act now requires safety and effectiveness assessments in pediatric subpopulation