ACETAMINOPHEN

FDA-1993-P-0055

The FDA is withdrawing approval of 128 suitability petitions that were previously approved to permit abbreviated new drug applications for drugs with different active ingredients, dosage forms, or routes of administration than their reference listed drugs, because no ANDAs were submitted and the Ped

FDA-1993-P-0018

The Food and Drug Administration is withdrawing approval of 128 suitability petitions that had been previously approved to permit abbreviated new drug applications for drugs with different active ingredients, dosage forms, or routes of administration compared to their reference listed drugs. The wit

FDA-1990-P-0454

The Food and Drug Administration is withdrawing approval of 128 suitability petitions that had been granted prior to the enactment of the Pediatric Research Equity Act of 2003 because no abbreviated new drug applications were ever submitted for these drugs, and any such applications submitted after

FDA-1986-P-0033

The FDA is withdrawing approval of 128 suitability petitions that had been approved prior to the Pediatric Research Equity Act of 2003 because no abbreviated new drug applications were ever submitted for these petitions, and PREA now requires safety and effectiveness assessments in pediatric subpopu

FDA-1986-P-0002

The Food and Drug Administration withdrew approval of 128 suitability petitions that had previously permitted abbreviated new drug applications to be submitted for drugs with different active ingredients, dosage forms, or routes of administration from their reference listed drugs, because the Pediat

FDA-1986-P-0014

The FDA is withdrawing approval of 128 suitability petitions that had previously permitted abbreviated new drug applications (ANDAs) for drugs with different active ingredients, dosage forms, or routes of administration from their reference listed drugs. The withdrawal is required by the Pediatric R

FDA-1986-P-0013

The Food and Drug Administration is withdrawing its approval of 128 suitability petitions because the Pediatric Research Equity Act of 2003 now requires that drug applications submitted on or after April 1, 1999 for a new active ingredient, new indication, new dosage form, new dosing regimen, or new