FDA Approval Activities for this Drug…

Isordil Sublingual (isosorbide dinitrate) Tablets 2.5, 5 and 10 mg, Wyeth-Ayerst NDA 12-940/S-044 9/16/01 11/21/02 Isordil Titradose (isosorbide dinitrate) Tablets, 5, 10, 20, 30, & 40 mg, Wyeth-Ayerst NDA 12-093/S-044 9/26/01 11/8/02 Isosorbide Dinitrate Extended-release Tablets, 40 mg, Inwood , ANDA 40-009 12/30/98 1/24/02 Isosorbide Mononitrate Extended-release Tablets, 60 mg, Zenith Goldline ANDA 75-448 6/19/00 10/30/00 Isosorbide Mononitrate Extended-release Tablets, 30 mg, 60 mg, & 120 mg, KV Pharmaceutical ANDA 75-395 3/16/00 3/21/00 Isosorbide Mononitrate Tablets, 10 mg and 20 mg, Purepac Pharmaceutical Company ANDA 75-037 10/30/98 11/2/98 Isosorbide Mononitrate Tablets, 20 mg, Westward Pharmaceutical Corp. ANDA 75-361 10/5/00 10/30/00 Isosorbide Mononitrate Extended-release tablets, 60 mg, Elan Pharmaceutical Research ANDA 75-041 9/22/98 9/23/98 8/24/01 8/24/01 Isosorbide Mononitrate Extended-release Tablets, 30 mg and 60 mg, Purepac Pharmaceutical ANDA 75-306 12/31/98 Isosorbide Mononitrate Tablets, 20 mg, Teva USA ANDA 75-147 11/27/98 1/2/02 1/2/02 1/2/02 Isosorbide Mononitrate Extended-release Tablets, 60 mg, Brightstone Pharma ANDA 75-166 10/7/99 12/30/99 Isosorbide Mononitrate Extended-release Tablets, 60 mg, Kremers Urban ANDA 75-155 10/30/98 11/3/98 Isosorbride Mononitrate Extended-release Tablets, 60 mg, Dexcel Ltd. ANDA 75-522 ISOSORBIDE DINITRATE Capsule, Extended Release; 40MG DILATRATE-SR SCHWARZ 016776 ISOSORBIDE DINITRATE Tablet, Chewable; 10MG SORBITRATE ASTRAZENECA 040009 ISOSORBIDE DINITRATE Tablet, Extended Release; 40MG ISOSORBIDE DINITRATE INWOOD 086405 ISOSORBIDE DINITRATE Tablet; 20MG SORBITRATE ASTRAZENECA 088125 ISOSORBIDE DINITRATE Tablet; 40MG SORBITRATE ASTRAZENECA 012093 ISOSORBIDE DINITRATE Tablet; 10MG ISORDIL BIOVAIL 012093 ISOSORBIDE DINITRATE Tablet; 20MG ISORDIL BIOVAIL 012093 ISOSORBIDE DINITRATE Tablet; 30MG ISORDIL BIOVAIL 012093 ISOSORBIDE DINITRATE Tablet; 40MG ISORDIL BIOVAIL 012093 ISOSORBIDE DINITRATE Tablet; 5MG ISORDIL BIOVAIL 086223 ISOSORBIDE DINITRATE Tablet; 10MG ISOSORBIDE DINITRATE Geneva 089367 ISOSORBIDE DINITRATE Tablet; 20MG ISOSORBIDE DINITRATE Geneva 086221 ISOSORBIDE DINITRATE Tablet; 5MG ISOSORBIDE DINITRATE Geneva 086925 ISOSORBIDE DINITRATE Tablet; 10MG ISOSORBIDE DINITRATE Par 087537 ISOSORBIDE DINITRATE Tablet; 20MG ISOSORBIDE DINITRATE Par 087946 ISOSORBIDE DINITRATE Tablet; 30MG ISOSORBIDE DINITRATE Par 086923 ISOSORBIDE DINITRATE Tablet; 5MG ISOSORBIDE DINITRATE Par 086032 ISOSORBIDE DINITRATE Tablet; 10MG ISOSORBIDE DINITRATE Watson 086034 ISOSORBIDE DINITRATE Tablet; 5MG ISOSORBIDE DINITRATE Watson 086066 ISOSORBIDE DINITRATE Tablet; 10MG ISOSORBIDE DINITRATE West Ward 088088 ISOSORBIDE DINITRATE Tablet; 20MG ISOSORBIDE DINITRATE West Ward 086067 ISOSORBIDE DINITRATE Tablet; 5MG ISOSORBIDE DINITRATE West Ward 012940 ISOSORBIDE DINITRATE Tablet; Sublingual 10MG ISORDIL BIOVAIL 012940 ISOSORBIDE DINITRATE Tablet; Sublingual 2.5MG ISORDIL BIOVAIL 012940 ISOSORBIDE DINITRATE Tablet; Sublingual 5MG ISORDIL BIOVAIL 086225 ISOSORBIDE DINITRATE Tablet; Sublingual 2.5MG ISOSORBIDE DINITRATE Geneva 086222 ISOSORBIDE DINITRATE Tablet; Sublingual 5MG ISOSORBIDE DINITRATE Geneva 086033 ISOSORBIDE DINITRATE Tablet; Sublingual 2.5MG ISOSORBIDE DINITRATE Watson 086031 ISOSORBIDE DINITRATE Tablet; Sublingual 5MG ISOSORBIDE DINITRATE Watson 086054 ISOSORBIDE DINITRATE Tablet; Sublingual 2.5MG ISOSORBIDE DINITRATE West Ward 086055 ISOSORBIDE DINITRATE Tablet; Sublingual 5MG ISOSORBIDE DINITRATE West Ward 075166 ISOSORBIDE MONONITRATE Tablet, Extended Release; 60MG ISOSORBIDE MONONITRATE BRIGHTSTONE 075522 ISOSORBIDE MONONITRATE Tablet, Extended Release; 60MG ISOSORBIDE MONONITRATE DEXCEL LTD 075041 ISOSORBIDE MONONITRATE Tablet, Extended Release; 60MG ISOSORBIDE MONONITRATE ELAN 075448 ISOSORBIDE MONONITRATE Tablet, Extended Release; 120MG ISOSORBIDE MONONITRATE Ivax 075448 ISOSORBIDE MONONITRATE Tablet, Extended Release; 30MG ISOSORBIDE MONONITRATE Ivax 075448 ISOSORBIDE MONONITRATE Tablet, Extended Release; 60MG ISOSORBIDE MONONITRATE Ivax 075155 ISOSORBIDE MONONITRATE Tablet, Extended Release; 120MG ISOSORBIDE MONONITRATE KREMERS URBAN 075155 ISOSORBIDE MONONITRATE Tablet, Extended Release; 30MG ISOSORBIDE MONONITRATE KREMERS URBAN 075155 ISOSORBIDE MONONITRATE Tablet, Extended Release; 60MG ISOSORBIDE MONONITRATE KREMERS URBAN 075395 ISOSORBIDE MONONITRATE Tablet, Extended Release; 120MG ISOSORBIDE MONONITRATE KV 075395 ISOSORBIDE MONONITRATE Tablet, Extended Release; 30MG ISOSORBIDE MONONITRATE KV 075395 ISOSORBIDE MONONITRATE Tablet, Extended Release; 60MG ISOSORBIDE MONONITRATE KV 075306 ISOSORBIDE MONONITRATE Tablet, Extended Release; 30MG ISOSORBIDE MONONITRATE Purepac 075306 ISOSORBIDE MONONITRATE Tablet, Extended Release; 60MG ISOSORBIDE MONONITRATE Purepac 020225 ISOSORBIDE MONONITRATE Tablet, Extended Release; 120MG IMDUR SCHERING 020225 ISOSORBIDE MONONITRATE Tablet, Extended Release; 30MG IMDUR SCHERING 020225 ISOSORBIDE MONONITRATE Tablet, Extended Release; 60MG IMDUR SCHERING 019091 ISOSORBIDE MONONITRATE Tablet; 20MG ISMO ESP 075037 ISOSORBIDE MONONITRATE Tablet; 10MG ISOSORBIDE MONONITRATE Purepac 075037 ISOSORBIDE MONONITRATE Tablet; 20MG ISOSORBIDE MONONITRATE Purepac 020215 ISOSORBIDE MONONITRATE Tablet; 10MG MONOKET SCHWARZ 020215 ISOSORBIDE MONONITRATE Tablet; 20MG MONOKET SCHWARZ 075147 ISOSORBIDE MONONITRATE Tablet; 20MG ISOSORBIDE MONONITRATE Teva 075361 ISOSORBIDE MONONITRATE Tablet; 20MG ISOSORBIDE MONONITRATE West Ward | Isosorbide Mononitrate Extended-Release Tablets, West-Ward Pharmaceutical, Approval

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