Endo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications

---------------------------------- Application No. Drug Applicant ------------------------------------------------------------------------ NDA 007337.............. Percodan (aspirin; Endo Operations oxycodone Limited c/o Endo USA, hydrochloride (HCl)) Inc., 9 Great Valley Tablets, 325 Parkway, Malvern, PA milligrams (mg); 19355. 4.8355 mg. Percodan (aspirin; oxycodone HCl; oxycodone terephthalate) Tablets, 325 mg; 4.5 mg; 0.38 mg.. Percodan-Demi (aspirin; oxycodone HCl; oxycodone terephthalate) Tablets, 325 mg; 4.5 mg; 0.19 mg. NDA 017376.............. Septra Monarch (sulfamethoxazole; Pharmaceuticals, LLC trimethoprim) c/o Pfizer Inc., 66 Tablets, 80 mg; 400 Hudson Blvd. East, mg. New York, NY 10001. Septra DS (sulfamethoxazole; trimethoprim) Tablets, 160 mg; 800 mg.. NDA 017994.............. Psorcon E (diflorasone Pfizer Inc., 66 Hudson diacetate) Ointment, Blvd. East, New York, 0.05%. NY 10001. NDA 018701.............. Haldol (haloperidol Janssen decanoate) Pharmaceuticals, Injectable, Inc., c/o Janssen equivalent to (EQ) 50 Research and mg base/milliliter Development, 920 U.S. (mL) and EQ 100 mg Highway 202, P.O. Box base/mL. 300, Raritan NJ 08869- 0602. NDA 019151.............. Rythmol (propafenone GlaxoSmithKline LLC, HCl) Tablets, 150 mg, 2929 Walnut St., 225 mg, and 300 mg. Suite 1700, Philadelphia, PA 19104. NDA 019260.............. Psorcon (diflorasone Pfizer Inc., 66