Propoxyphene Drug Products for Which Application Holders Requested Withdrawal of Approval

Application No.	Drug	Applicant or holder
NDA 010996	Darvon Compound (aspirin, caffeine, and propoxyphene HCl) Capsules, 389 milligrams (mg)/32.4 mg/32 mgDarvon Compound-65 (aspirin, caffeine, and propoxyphene HCl) Capsules, 389 mg/32.4 mg/65 mgDarvon with ASA (aspirin and propoxyphene HCl) Capsules, 325 mg/65 mg	Xanodyne Pharmaceuticals, Inc., One Riverfront Pl., Newport, KY 41071.
NDA 010997	Darvon (propoxyphene HCl) Capsules, 32 mg and 65 mg	Do.
NDA 016829	Darvon-N with ASA (aspirin and propoxyphene napsylate) Capsules, 325 mg/100 mg	AAIPharma Inc., 2320 Scientific Park Dr., Wilmington, NC 28405.
NDA 016844	Darvocet (acetaminophen and propoxyphene HCl) Tablets, 325 mg/32.5 mg	Do.
NDA 016861	Darvon-N (propoxyphene napsylate) Suspension, 50 mg/5 milliliters	Do.
NDA 016862	Darvon-N (propoxyphene napsylate) Tablets, 100 mg	Do.
NDA 016863	Darvon-N with ASA (aspirin and propoxyphene napsylate) Tablets, 325 mg/100 mg	Do.
NDA 017122	Darvocet-N 50 (acetaminophen and propoxyphene napsylate) Tablets, 325 mg/50 mgDarvocet-N 100 (acetaminophen and propoxyphene napsylate) Tablets, 650 mg/100 mg	Xanodyne Pharmaceuticals, Inc.
ANDA 040139	Acetaminophen and Propoxyphene HCl Tablets, 650 mg/65 mg	Watson Laboratories, Inc., 400 Interpace Pkwy., Parsippany, NJ 07054.
ANDA 040507	Acetaminophen and Propoxyphene HCl Tablets, 650 mg/65 mg	Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL 35811.
ANDA 040569	Propoxyphene HCl Capsules, 65 mg	Mylan Pharmaceuticals, 781 Chestnut Ridge Rd., Morgantown, WV 26505.
ANDA 040908	Propoxyphene HCl Capsules, 65 mg	Vintage Pharmaceuticals.
ANDA 070115	Acetaminophen and Propoxyphene Napsylate Tablets, 325 mg/50 mg	Mutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124.
ANDA 070116	Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mg	Do.
ANDA 070145	Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mg	Mylan Pharmaceuticals.
ANDA 070146	Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mg	IVAX Pharmaceuticals,Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 070443	Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mg	Sandoz Inc., 2555 W. Midway Blvd., Broomfield, CO 80038.
ANDA 070615	Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mg	Mutual Pharmaceutical Co., Inc.
ANDA 070771	Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mg	Do.
ANDA 070775	Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mg	Do.
ANDA 070910	Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mg	Actavis Elizabeth LLC, 200 Elmora Ave., Elizabeth, NJ 07202.
ANDA 072195	Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mg	Mylan Pharmaceuticals.
ANDA 074119	Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mg	Teva Pharmaceuticals, 1090 Horsham Rd., North Wales, PA 19454.
ANDA 074843	Acetaminophen and Propoxyphene Napsylate Tablets, 325 mg/50 mg and 650 mg/100 mg	Vintage Pharmaceuticals.
ANDA 075738	Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mg	Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO 63042.
ANDA 076429	Darvocet A500 (acetaminophen and propoxyphene napsylate) Tablets, 500 mg/100 mg	Xanodyne Pharmaceuticals, Inc.
ANDA 076609	Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mg	Watson Laboratories, Inc., 4955 Orange Dr., Fort Lauderdale, FL 33314.
ANDA 076743	Acetaminophen and Propoxyphene Napsylate Tablets, 325 mg/100 mg	Cornerstone Therapeutics Inc., 1255 Crescent Green Dr., Cary, NC 27518.
ANDA 076750	Acetaminophen and Propoxyphene Napsylate Tablets, 500 mg/100 mg	Do.
ANDA 077196	Acetaminophen and Propoxyphene Napsylate Tablets, 500 mg/100 mg	Watson Laboratories, Inc.
ANDA 077677	Acetaminophen and Propoxyphene Napsylate Tablets, 325 mg/50 mg and 650 mg/100 mg	Wockhardt USA LLC, 20 Waterview Blvd., Parsippany, NJ 07054.
ANDA 077821	Acetaminophen and Propoxyphene Napsylate Tablets 650 mg/100 mg	Mirror Pharmaceuticals LLC, 140 New Dutch Ln., Fairfield, NJ 07004.
ANDA 080044	Aspirin, Caffeine, and Propoxyphene HCl Capsules, 389 mg/32.4 mg/65 mg	Sandoz, Inc., 4700 Sandoz Dr., Wilson, NC 27893.
ANDA 080269	Propoxyphene HCl Capsules, 65 mg	Par Pharmaceuticals, Inc., 1 Ram Ridge Rd., Spring Valley, NJ 10977.
ANDA 080530	Dolene (propoxyphene HCl) Capsules, 65 mg	Heritage Pharmaceuticals Inc., 105 Fieldcrest Ave., Edison, NJ 08837.
ANDA 080783	Propoxyphene HCl Capsules, 65 mg	Valeant Pharmaceuticals North America LLC, 700 Route 202/206 North, Bridgewater, NJ 08807.
ANDA 083101	Aspirin, Caffeine, and Propoxyphene HCl Capsules, 389 mg/32.4 mg/65 mg	Sandoz, Inc., 2555 W. Midway Blvd., Broomfield, CO 80038.
ANDA 083113	Propoxyphene HCl Capsules, 65 mg	Private Formulations Inc.
ANDA 083125	Propoxyphene HCl Capsules, 65 mg	Sandoz, Inc.
ANDA 083185	Propoxyphene HCl Capsules, 65 mg	Nexgen Pharma, Inc., 17802 Gillette Ave., Irvine, CA 92614.
ANDA 083186	Propoxyphene HCl Capsules, 65 mg	Mutual Pharmaceutical Co. Inc.
ANDA 083464	Propoxyphene HCl Capsules, 32 mg	Private Formulations Inc.
ANDA 083501	Propoxyphene HCl Capsules, 65 mg	West-Ward Pharmaceutical Corp., 435 Industrial Way West, Eatontown, NJ 07724.
ANDA 083528	Propoxyphene HCl Capsules, 32 mg	Mylan Pharmaceuticals, 781 Chestnut Ridge Rd., Morgantown, WV 26505.
ANDA 083688	Propoxyphene HCl Capsules, 65 mg	Sandoz Inc., 506 Carnegie Center, Princeton, NJ 08540.
ANDA 083689	Acetaminophen and Propoxyphene HCl Tablets, 325 mg/32 mg	Mylan Pharmaceuticals.
ANDA 083870	Propoxyphene HCl Capsules, 65 mg	Sandoz, Inc.
ANDA 083978	Acetaminophen and Propoxyphene HCl Tablets, 650 mg/65 mg	Mylan Pharmaceuticals.
ANDA 084014	Propoxyphene HCl Capsules, 32 mg	Sandoz, Inc., 4700 Sandoz Dr., Wilson, NC 27893.
ANDA 084999	Wygesic (acetaminophen and propoxyphene HCl) Tablets, 650 mg/65 mg	Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Dr., Detroit, MI 48202.
ANDA 086495	Propoxyphene HCl Capsules, 65 mg	Sandoz, Inc.
ANDA 088615	Propoxyphene HCl Capsules, 65 mg	Teva Pharmaceuticals.
ANDA 089025	Aspirin, Caffeine, and Propoxyphene HCl Capsules, 389 mg/32.4 mg/65 mg	Do.
ANDA 089959	Acetaminophen and Propoxyphene HCl Tablets, 650 mg/65 mg