lördag 19 april 2014

Propoxyphene Drug Products for Which Application Holders Requested Withdrawal of Approval


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

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