CHLORZOXAZONE

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-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-0005

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

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-1993-P-0029

The Food and Drug Administration is withdrawing 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 no a

FDA-1996-P-0022

The FDA, through this February 2007 notice, withdrew approval of 128 suitability petitions filed by various pharmaceutical companies because no ANDAs were submitted for these drugs under the petitions before the Pediatric Research Equity Act took effect on April 1, 1999, and the petitions no longer

FDA-1996-P-0034

The FDA is withdrawing approval of 128 suitability petitions that were approved prior to the December 2003 enactment of the Pediatric Research Equity Act. The withdrawals are necessary because no ANDAs were submitted for these drugs despite the petitions' approval, and any ANDA submissions after Apr

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 The withdrawn petitions had previously approved ANDAs for drugs with different act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-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-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

FDA-1986-P-0032

The Food and Drug Administration, on February 23, 2007, withdrew approval of 128 suitability petitions filed by various pharmaceutical companies because no Abbreviated New Drug Applications were submitted under these petitions prior to April 1, 1999, and the Pediatric Research Equity Act now require

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-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-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