Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.