METHYLTESTOSTERONE

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-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-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-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