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← Snapshot 21

Orange Book snapshot 21: Products

Products page 8 of 799 · 39,901 matching rows.

Source row, Application type, Application number table
Source rowApplication typeApplication numberProduct numberIngredient rawDosage form / route rawDosage formRouteTrade nameApplicantStrength rawTE rawTE JSONApproval dateApproval date rawApproved before 1982RLDRSProduct typeApplicant full nameRaw row SHA-256
352A075785002OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLEIMPAX LABS20MGAB["AB"]2007-10-22Oct 22, 2007NoNoNoRXIMPAX LABORATORIES INC96d8fc1f6dd57f844b31f6e0bc0388a4cfe719285f75d52c08164d9d45cd70f1
353A075785003OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLEIMPAX LABS40MGAB["AB"]2009-01-21Jan 21, 2009NoNoNoRXIMPAX LABORATORIES INC15b14e07a2bf190e3f82b12cf28e9bbfc1cf6b2447c2538b0f6dda3e523cc79b
354A075410001OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLELANNETT CO INC10MGAB["AB"]2002-11-01Nov 1, 2002NoNoNoRXLANNETT CO INCba7271a7f7ffa7d518c00a1822e150a07a42dc9bdc45e7bbe6a94696ff156f53
355A075410002OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLELANNETT CO INC20MGAB["AB"]2002-11-01Nov 1, 2002NoNoNoRXLANNETT CO INC96eedc12e39c48b806be4120ed170e04ecb0bdc854bf6bb4362c129abc9de63e
356A075410003OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLELANNETT CO INC40MGAB["AB"]2009-01-23Jan 23, 2009NoNoNoRXLANNETT CO INC564d7e3ebc746ba303ba75ec9948788fbca6151bef7133cbcf74efbb946a95c3
357A202384001OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLELUPIN LTD40MG[]2015-08-25Aug 25, 2015NoNoNoDISCNLUPIN LTDb0337b00609cc9dd26a5bec33f35d63a936cb8a9d275f0a2ae8732cb3a9d0f31
358A075876001OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLEMYLAN10MG[]2003-05-29May 29, 2003NoNoNoDISCNMYLAN PHARMACEUTICALS INCd4abdf91cb62ddd7afff0a6a18e5c7a49cf28bc198a4acf1cf9a60a78e6b983c
359A205070001OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLEMYLAN10MG[]2018-06-29Jun 29, 2018NoNoNoDISCNMYLAN PHARMACEUTICALS INCdbb5943698d1129d8ab49955d90746e0d12fdf37b845ff9a383048afb7570c3e
360A075876002OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLEMYLAN20MG[]2003-05-29May 29, 2003NoNoNoDISCNMYLAN PHARMACEUTICALS INC418fba4110d0eeb337c74ff6c9d1beb182f72b7905ceba657552e32ef0ecfdac
361A205070002OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLEMYLAN20MG[]2018-06-29Jun 29, 2018NoNoNoDISCNMYLAN PHARMACEUTICALS INCd86d457a626f8a8afb9ff189bf8ce1a5f416780ea766ce5c12291320a0cff052
362A075876003OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLEMYLAN40MG[]2009-01-21Jan 21, 2009NoNoNoDISCNMYLAN PHARMACEUTICALS INCee89cbc39129c17b2c9135ff2a2349ed9c67685d8c788d20db830afb59b993a6
363A205070003OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLEMYLAN40MG[]2018-06-29Jun 29, 2018NoNoNoDISCNMYLAN PHARMACEUTICALS INC5436bc8fa5373382b1c836652a9f65547f6cde16d22d1ae05a1d0ca3c0950f45
364A075757001OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLESANDOZ10MGAB["AB"]2003-01-28Jan 28, 2003NoNoNoRXSANDOZ INC456edd694f6d5a58bc3b03b56f48eb0b8502331fad56f84c65406ce9471acd38
365A075757002OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLESANDOZ20MGAB["AB"]2003-01-28Jan 28, 2003NoNoYesRXSANDOZ INC6846fb1881ec5fc5e89602df0df6509a1f38a0ae9ecf35704c6c20ecdb60e006
366A076515001OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLESANDOZ40MGAB["AB"]2009-01-21Jan 21, 2009NoNoYesRXSANDOZ INC89f04f62f2863053195ef5a58b49d0fe132c91bdfb48cae949da71e687f841df
367A204661001OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLETEVA PHARMS USA20MGAB["AB"]2017-06-13Jun 13, 2017NoNoNoRXTEVA PHARMACEUTICALS USAb8e6ad4d786bdeee5a5b68c8907df6426b085e567482bbd575082ecce527140b
368A204661002OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLETEVA PHARMS USA40MG[]2017-06-13Jun 13, 2017NoNoNoDISCNTEVA PHARMACEUTICALS USA9fb9a0598545254ed5e78beb153a9e6b88e2dcafcf0588ec5dcaa4bf82af6112
369A212977001OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLEXIROMED10MGAB["AB"]2020-12-10Dec 10, 2020NoNoNoRXXIROMED PHARMA ESPANA SL1506052c99f239b192023ae4057819fe52daf38ee30a5ee0726ce155e167c63b
370A212977002OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLEXIROMED20MGAB["AB"]2020-12-10Dec 10, 2020NoNoNoRXXIROMED PHARMA ESPANA SL9034ebc3fd8b78b02d3cb92233e97fbd0ce2f08a1445f179bf0e289dae86f380
371A091352001OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLEZYDUS PHARMS USA INC10MGAB["AB"]2012-11-19Nov 19, 2012NoNoNoRXZYDUS PHARMACEUTICALS USA INC381326e04e56fc4d754ee557b0b631f3c9489488f2bf33278d56f0e37b46b1bc
372A091352002OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLEZYDUS PHARMS USA INC20MGAB["AB"]2012-11-19Nov 19, 2012NoNoNoRXZYDUS PHARMACEUTICALS USA INCc8d3eb8ee0236a4c61002635ced8cf9c49e2c3a678e51890574d9af5e688f8a3
373A091352003OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALOMEPRAZOLEZYDUS PHARMS USA INC40MGAB["AB"]2012-11-19Nov 19, 2012NoNoNoRXZYDUS PHARMACEUTICALS USA INC501461197e63c8a0524d3da174654c09ee7d0bb6c4ad60ab7d5cfc70653ce8b3
374N020406001LANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALPREVACIDTAKEDA PHARMS USA15MGAB["AB"]1995-05-10May 10, 1995NoYesNoRXTAKEDA PHARMACEUTICALS USA INC975e2a464b709453819e33e4a66403d2146ca5b09612b6c1464ae926e0f4e107
375N020406002LANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALPREVACIDTAKEDA PHARMS USA30MGAB["AB"]1995-05-10May 10, 1995NoYesYesRXTAKEDA PHARMACEUTICALS USA INCd591a87170698fa70b86bc26b19658d32d6826fa8c2117d4005d12430a3cc7ad
376N022327001LANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALPREVACID 24 HRPERRIGO PHARMA INTL15MG[]2009-05-18May 18, 2009NoYesYesOTCPERRIGO PHARMA INTERNATIONAL DESIGNATED ACTIVITY CO71aa6bf85f57f8c8a731acc115013d09a037cb66949129c10a0e1703d0d7b7e1
377N019810003OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALPRILOSECASTRAZENECA10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1995-10-05Oct 5, 1995NoYesNoDISCNASTRAZENECA PHARMACEUTICALS LP6b55312fc5cae3d4cafeaf5e9ca86b561107999d90ec5e3f22b4845e9ed60371
378N019810001OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALPRILOSECASTRAZENECA20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1989-09-14Sep 14, 1989NoYesNoDISCNASTRAZENECA PHARMACEUTICALS LP10239db89b4b167c25d6be73081c20ed8e5fd5bbaf3cc9d3463b8d2401e94fc4
379N019810002OMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALPRILOSECASTRAZENECA40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1998-01-15Jan 15, 1998NoYesNoDISCNASTRAZENECA PHARMACEUTICALS LP357d375705f9e6ce2a8a0b4c9f66c19efb0da9ed6ed15f9ba98a3a72b4536ddd
380N021235001FLUOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALPROZAC WEEKLYLILLYEQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]2001-02-26Feb 26, 2001NoYesNoDISCNELI LILLY AND CO0a4d4db4c557c8aaaed335fa0f67581fbd5173e33a4623f7a2c5eb255c31e49e
381N021183001DIDANOSINECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALVIDEX ECBRISTOL MYERS SQUIBB125MG[]2000-10-31Oct 31, 2000NoYesNoDISCNBRISTOL MYERS SQUIBB CO942a44c68c46d3eda278feb8b2d2f14414b671953b5b1c1ff995164b8c268282
382N021183002DIDANOSINECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALVIDEX ECBRISTOL MYERS SQUIBB200MG[]2000-10-31Oct 31, 2000NoYesNoDISCNBRISTOL MYERS SQUIBB CO55ecbe51227a827e2efcbbd3092fca6c0f9e597f64a97e91396a95d28ea228e5
383N021183003DIDANOSINECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALVIDEX ECBRISTOL MYERS SQUIBB250MG[]2000-10-31Oct 31, 2000NoYesNoDISCNBRISTOL MYERS SQUIBB CO8417f1b7d5a964bab49260d1ca46683f178459ce5883aba7cb4227df31765734
384N021183004DIDANOSINECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALVIDEX ECBRISTOL MYERS SQUIBB400MG[]2000-10-31Oct 31, 2000NoYesNoDISCNBRISTOL MYERS SQUIBB CO345184d9739dc0e9c208b835dfd81610fda61907fd4981383a2a2112647679d7
385N204736001RABEPRAZOLE SODIUMCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALACIPHEX SPRINKLEAYTU5MG[]2013-03-26Mar 26, 2013NoYesNoDISCNAYTU BIOSCIENCE INCea12d590c7338967fdb4573a12c394b1fbf00c94c1bae365966158e73635a0d8
386N204736002RABEPRAZOLE SODIUMCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALACIPHEX SPRINKLEAYTU10MG[]2013-03-26Mar 26, 2013NoYesNoDISCNAYTU BIOSCIENCE INCf385a4a9cc972e5f710f004e229e281ae727917e0e6d79fda109b41da242c2d7
387N210296001MONOMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALBAFIERTAMBANNER LIFE SCIENCES95MG[]2020-04-28Apr 28, 2020NoYesYesRXBANNER LIFE SCIENCES LLCc344f19660e347109ac4500561580d959d4da0b7302d88d89e9e71f9fa7fa10f
388N204412001MESALAMINECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDELZICOLAPIL400MGAB["AB"]2013-02-01Feb 1, 2013NoYesYesRXALLERGAN PHARMACEUTICALS INTERNATIONAL LTD404f57e7486aa63090a76299ff7911dac9c3787bd2f074bb376fe84814afcb75
389N022287001DEXLANSOPRAZOLECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDEXILANTTAKEDA PHARMS USA30MG[]2009-01-30Jan 30, 2009NoYesNoRXTAKEDA PHARMACEUTICALS USA INC929848af5cabfe4a553bdbc08a0df285cd0cb0448940bbb57adaa8d08386e002
390N022287002DEXLANSOPRAZOLECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDEXILANTTAKEDA PHARMS USA60MGAB["AB"]2009-01-30Jan 30, 2009NoYesYesRXTAKEDA PHARMACEUTICALS USA INC2a07be0bb9e2201780753965608248ce360e9ba39136bde9d8bd261a4d3f9915
391A202294001DEXLANSOPRAZOLECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDEXLANSOPRAZOLEPAR PHARM INC60MGAB["AB"]2017-04-19Apr 19, 2017NoNoNoRXPAR PHARMACEUTICAL INC688614675815560de2ab8a375c43bf60e0a1b04078e521ef866dca44b01667f3
392A210499001DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEACCORD HLTHCARE120MGAB["AB"]2020-09-24Sep 24, 2020NoNoNoRXACCORD HEALTHCARE INC1ef0a0c190c31a469e299190497b84b5805523be9e88cccdf524fa86c07bd326
393A210499002DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEACCORD HLTHCARE240MGAB["AB"]2020-09-24Sep 24, 2020NoNoNoRXACCORD HEALTHCARE INC3e74062f0778c61111ceaf48c9fcc167fdf13ddb9b49fd8159cfb97c1828373a
394A210440001DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEALKEM LABS LTD120MGAB["AB"]2020-09-24Sep 24, 2020NoNoNoRXALKEM LABORATORIES LTD703eaec77ed288841d3ccef594a567b5b3014f40f7e776f9a5063360bfdadbe7
395A210440002DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEALKEM LABS LTD240MGAB["AB"]2020-09-24Sep 24, 2020NoNoNoRXALKEM LABORATORIES LTD7653f12639ecf8db268e179285c8d537b962638e1d15fc8c04a15c58859c1dbd
396A210402001DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEAMNEAL120MGAB["AB"]2020-09-24Sep 24, 2020NoNoNoRXAMNEAL EU LTDb05628abff34c8e89bfeb7dd1fc574fea281b8e3698f72ae666cc80479a227b2
397A210402002DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEAMNEAL240MGAB["AB"]2020-09-24Sep 24, 2020NoNoNoRXAMNEAL EU LTDeef4c2eb983b862c8ec48b775aad1c626eaddc33bc33219093c58beb96caa27f
398A210305001DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATECIPLA120MGAB["AB"]2020-09-24Sep 24, 2020NoNoNoRXCIPLA LTD62b46dd9e061096fcf7afd90791f1dcf2c418e83f9e8f7bbcbfdc15e3f9ff5b3
399A210305002DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATECIPLA240MGAB["AB"]2020-09-24Sep 24, 2020NoNoNoRXCIPLA LTDcdfd658519910a8fe8280087f849c0ca8765a0edb118ca494440c2aed4fa6b98
400A210309001DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEGLENMARK PHARMS LTD120MGAB["AB"]2020-10-06Oct 6, 2020NoNoNoRXGLENMARK PHARMACEUTICALS LTD93f770324443ec0ae503c4583109982a0cb706247bd2a3f2722cf5e107ca9522
401A210309002DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEGLENMARK PHARMS LTD240MGAB["AB"]2020-10-06Oct 6, 2020NoNoNoRXGLENMARK PHARMACEUTICALS LTDea6cd5ae1f2785a1dfbf3c23a463dbc1224778874a3700481c06d6f9ffdde154