Federal Register Notice: FDA is correcting a 2/11/09 Federal Register notice that withdrew approval of 103 NDAs and 35 ANDAs from multiple applicants. It inadvertently withdrew approval of NDA 50-435 for Pfizer’s Geocillin (carbenicillin indanyl sodium) tablets. FDA confirms that approval of NDA 50-435 is still in effect. To view this notice, click here.
