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Orange Book snapshot 21: Products

Products page 38 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
1852A061658002TETRACYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALBRISTACYCLINEBRISTOL500MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNBRISTOL LABORATORIES INC DIV BRISTOL MYERS CO27786400bf9879363b07df2aadff375f7c809f85d01decf126c946aeeecef497
1853A061888002TETRACYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALBRISTACYCLINEBRISTOL500MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNBRISTOL LABORATORIES INC DIV BRISTOL MYERS CO4a6929d23a86352b9cc93901e4f74a8daa8a8465bf64bafa16b6ebf6b93e925e
1854A075100001BROMOCRIPTINE MESYLATECAPSULE;ORALCAPSULEORALBROMOCRIPTINE MESYLATELEK PHARMEQ 5MG BASE[]1998-12-10Dec 10, 1998NoNoNoDISCNLEK PHARMACEUTICAL AND CHEMICAL CO DDb9e46818b5f439209f8bd9fee0ff3f159d2f315cd624f8816be003d929d24653
1855A077226001BROMOCRIPTINE MESYLATECAPSULE;ORALCAPSULEORALBROMOCRIPTINE MESYLATEMYLANEQ 5MG BASEAB["AB"]2005-04-04Apr 4, 2005NoNoYesRXMYLAN PHARMACEUTICALS INC16d1039f2b0837d514642643d5e371d4d76b6e47b22889e1187953db4ebb0d80
1856A078899001BROMOCRIPTINE MESYLATECAPSULE;ORALCAPSULEORALBROMOCRIPTINE MESYLATEZYDUS PHARMS USA INCEQ 5MG BASEAB["AB"]2008-07-30Jul 30, 2008NoNoNoRXZYDUS PHARMACEUTICALS USA INC7c80f34726020a78b39be11cc12e80a71f6dde65404a0623d535efa417616555
1857A085264001THEOPHYLLINECAPSULE;ORALCAPSULEORALBRONKODYLSANOFI AVENTIS US100MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNSANOFI AVENTIS US LLCf7d0c9dc8bbe64dc7f5320bcadd50403b0d33ae01d4b6738ef6e5740ea26e51d
1858A085264002THEOPHYLLINECAPSULE;ORALCAPSULEORALBRONKODYLSANOFI AVENTIS US200MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNSANOFI AVENTIS US LLC7a979484e7ffe589bfa44b48c8fe6a4fa818a13c308f6171cdb5497a47d101fe
1859N213217001ZANUBRUTINIBCAPSULE;ORALCAPSULEORALBRUKINSABEIGENE80MG[]2019-11-14Nov 14, 2019NoYesYesRXBEIGENE USA INC2df8c48854e07a7639b00723a3ed05b1bc921cd36b7ddeaeaff5200a51e81695
1860A088991001ACETAMINOPHEN; BUTALBITALCAPSULE;ORALCAPSULEORALBUCETMALLINCKRODT650MG;50MG[]1985-06-28Jun 28, 1985NoNoNoDISCNMALLINCKRODT CHEMICAL INC3b79549595bde4b78106c82823d33e7a70ebf92dd0b24c0f0608c598db9f8a08
1861A206724001BUDESONIDECAPSULE;ORALCAPSULEORALBUDESONIDEALVOGEN3MG[]2016-11-23Nov 23, 2016NoNoNoDISCNALVOGEN INC64d55f3fe054fbc89dccc136e8a61d07a5baa22c793b6c8943832d52f3dcd2a8
1862A206200001BUDESONIDECAPSULE;ORALCAPSULEORALBUDESONIDEAMNEAL PHARMS3MGAB["AB"]2017-07-31Jul 31, 2017NoNoNoRXAMNEAL PHARMACEUTICALS OF NEW YORK LLC5345a68cb90b8f5095c31b38ef9b352d59c015c3e9d415f4828c96afc7b72fa3
1863A090379001BUDESONIDECAPSULE;ORALCAPSULEORALBUDESONIDEBARR LABS DIV TEVA3MG[]2014-04-02Apr 2, 2014NoNoNoDISCNBARR LABORATORIES INC SUB TEVA PHARMACEUTICALS USA0d217273cc43f6242d80625fd654be5bf749ccd69619c14028b21006aa11525a
1864A206623001BUDESONIDECAPSULE;ORALCAPSULEORALBUDESONIDEMAYNE PHARMA3MGAB["AB"]2016-04-08Apr 8, 2016NoNoNoRXMAYNE PHARMA LLC25385ce9a9adf5c14a271f41245308791ea623378ce11dc4c4434bfb62a00b64
1865A090410001BUDESONIDECAPSULE;ORALCAPSULEORALBUDESONIDEMYLAN3MGAB["AB"]2011-05-16May 16, 2011NoNoNoRXMYLAN PHARMACEUTICALS INC8836f1944923d950d7590a5d793417297595be1ef93194f44e3f8a81e614ea7c
1866A207367001BUDESONIDECAPSULE;ORALCAPSULEORALBUDESONIDERISING3MGAB["AB"]2017-04-07Apr 7, 2017NoNoNoRXRISING PHARMA HOLDINGS INC8327600c5337d0d33b233d4394aee1bfc6ea58c7af982ceb179e0190377d604b
1867A209041001BUDESONIDECAPSULE;ORALCAPSULEORALBUDESONIDESCIECURE PHARMA INC3MGAB["AB"]2017-09-28Sep 28, 2017NoNoNoRXSCIECURE PHARMA INC53a10bb4146e2996341505a48d1f07da75a5d24ae83ed733ca9c5b0f8c498f29
1868A206134001BUDESONIDECAPSULE;ORALCAPSULEORALBUDESONIDEZYDUS PHARMS3MGAB["AB"]2017-05-04May 4, 2017NoNoNoRXZYDUS PHARMACEUTICALS USA INCf35d8746dd26f73824248ae766195b95da6c7529db3b594647140302eb0203dd
1869N021190001BUSPIRONE HYDROCHLORIDECAPSULE;ORALCAPSULEORALBUSPARBRISTOL MYERS SQUIBB5MG[]2000-12-20Dec 20, 2000NoNoNoDISCNBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTEd7a8d62429fee4788e839ab9b017d1abb74de70702bd26a319faa5623796264d
1870N021190002BUSPIRONE HYDROCHLORIDECAPSULE;ORALCAPSULEORALBUSPARBRISTOL MYERS SQUIBB7.5MG[]2000-12-20Dec 20, 2000NoNoNoDISCNBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE529b4de89e64e3dcb520d3440f6c339ed4653beea803502fd0a9f98e454c4cac
1871N021190003BUSPIRONE HYDROCHLORIDECAPSULE;ORALCAPSULEORALBUSPARBRISTOL MYERS SQUIBB10MG[]2000-12-20Dec 20, 2000NoNoNoDISCNBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTEf7e1e77372cb7d4f53c026e9840315da9c0df2698d008221c4697b48e0fc4168
1872N021190004BUSPIRONE HYDROCHLORIDECAPSULE;ORALCAPSULEORALBUSPARBRISTOL MYERS SQUIBB15MG[]2000-12-20Dec 20, 2000NoNoNoDISCNBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE6ea9264c9b58a9f8bb0a724ca05521bc031ef21b0bf93480ebcb9e00f57df803
1873A213115001ACETAMINOPHEN; BUTALBITALCAPSULE;ORALCAPSULEORALBUTALBITAL AND ACETAMINOPHENGRANULES PHARMS300MG;50MGAA["AA"]2019-11-22Nov 22, 2019NoNoNoRXGRANULES PHARMACEUTICALS INC75cb21f5e0bc44abf00aecc32669456c8a1b55f7dc38a8e658fd715598b8020b
1874A207313001ACETAMINOPHEN; BUTALBITALCAPSULE;ORALCAPSULEORALBUTALBITAL AND ACETAMINOPHENMAYNE PHARMA INC300MG;50MGAA["AA"]2017-12-27Dec 27, 2017NoNoYesRXMAYNE PHARMA INCaf34d0940fc342d13fff9e8613d8ae4af999e3b06c473f9585ac5f15d2c0306f
1875A204733001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAUROLIFE PHARMA LLC325MG;50MG;40MGAA["AA"]2018-09-26Sep 26, 2018NoNoNoRXAUROLIFE PHARMA LLCa3ab991eeb89e6b046484a81d9336d2e03811f079f021c12cd193b53beded429
1876A088825001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINEGILBERT LABS325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1984-12-05Dec 5, 1984NoNoNoDISCNGILBERT LABORATORIESc8da09074b8e4d7fad99c6d6522f84d29c78926c56bd0bbabad83705769d1e92
1877A088743001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINEGRAHAM DM325MG;50MG;40MG[]1985-07-18Jul 18, 1985NoNoNoDISCNDM GRAHAM LABORATORIES INC579a74755783337b3d0b1e8d28dc64edc925727bc9f3ff528c681c99fc0a5444
1878A088765001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINEGRAHAM DM325MG;50MG;40MG[]1985-03-27Mar 27, 1985NoNoNoDISCNDM GRAHAM LABORATORIES INC63c6664c4343958bf3a99266f9fb84e8839fdd98558b51106cefad033f24b3c8
1879A089067001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINEGRAHAM DM325MG;50MG;40MG[]1985-04-19Apr 19, 1985NoNoNoDISCNDM GRAHAM LABORATORIES INC7813ff48e48c4471112e43f7d5f4e59cbe7588ce7a6908d07421daf1fe33bb03
1880A213321001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINEGRANULES PHARMS300MG;50MG;40MGAA["AA"]2020-04-08Apr 8, 2020NoNoNoRXGRANULES PHARMACEUTICALS INC00d00f4980742be5c5463fdd491dfbe410afd58448f18e565991925cd2123b04
1881A040261001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINEHIKMA500MG;50MG;40MG[]1998-10-28Oct 28, 1998NoNoNoDISCNHIKMA PHARMACEUTICALS LLC7664c459f23b75adba4edfcae4955e2e2127d1a51ae0f8bb7dcc7394d5e2b251
1882A212082001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINELANNETT CO INC300MG;50MG;40MGAA["AA"]2019-12-17Dec 17, 2019NoNoNoRXLANNETT CO INCe6a4692fd65f45d702f7f41dacf2a6a6ee9c71be28852830ff6c9a226df9d4b9
1883A212083001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINELANNETT CO INC325MG;50MG;40MGAA["AA"]2019-12-17Dec 17, 2019NoNoNoRXLANNETT CO INCba5584386a0987879c73956194793c316b841e224c62e875dd015e48bdad0227
1884A040885001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINELGM PHARMA300MG;50MG;40MGAA["AA"]2009-11-16Nov 16, 2009NoNoYesRXLGM PHARMA SOLUTIONS LLC6ab443ab8e42efb19a7eb85fa73cc30879f815934c2f174959ad09fc3333b6e9
1885A088758001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINEMALLINCKRODT325MG;50MG;40MG[]1985-03-27Mar 27, 1985NoNoNoDISCNMALLINCKRODT CHEMICAL INC6eb39f5f727c04d5fbad4426cad1add6c175c38da7f2249cc62a15bc56a4a32c
1886A210817001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINEMAYNE PHARMA INC300MG;50MG;40MGAA["AA"]2019-12-17Dec 17, 2019NoNoNoRXMAYNE PHARMA INC374fd3685728493ced3593b81da9437b184cbb49d1fa05ea1d9270ef2f39d122
1887A089007001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINEMAYNE PHARMA INC325MG;50MG;40MGAA["AA"]1986-03-17Mar 17, 1986NoNoYesRXMAYNE PHARMA INC2e52d8c4942c14028ff52526d4a0f14616deb656f3b11efefe639e6db3097eef
1888A207118001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINENUVO PHARMS INC300MG;50MG;40MGAA["AA"]2016-10-28Oct 28, 2016NoNoNoRXNUVO PHAMACEUTICALS INCcf2fbd46f639350e1a17b0c0e1ed11a688fe88569f70ac38e36ae9a9080a9641
1889A213046001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINETARO PHARM INDS LTD300MG;50MG;40MGAA["AA"]2020-07-01Jul 1, 2020NoNoNoRXTARO PHARMACEUTICAL INDUSTRIES LTDb130d49ff367ab74d157ccd4400969510b5af6b317f8f30e3ea02dd2821de227
1890A206615001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN AND CAFFEINEXSPIRE PHARMA300MG;50MG;40MGAA["AA"]2017-08-04Aug 4, 2017NoNoNoRXXSPIRE PHARMA80ee6099986d6babcaff36142300f806551711f5fa75601510daaa9db3f55e68
1891A076528001ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEABLE325MG;50MG;40MG;30MG[]2003-08-21Aug 21, 2003NoNoNoDISCNABLE LABORATORIES INC8ba9e6529f41eb98183c82c4e60d65be932f877202f125bd1b669d645fb43a17
1892A075618001ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEHIKMA INTL PHARMS325MG;50MG;40MG;30MG[]2001-03-23Mar 23, 2001NoNoNoDISCNHIKMA INTERNATIONAL PHARMACEUTICALS LLC93a2819848d1d93154672998df2d12b23db988ec61e6d2b76dfea924073d207e
1893A076560002ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATELGM PHARMA300MG;50MG;40MG;30MG[]2012-07-19Jul 19, 2012NoNoNoRXLGM PHARMA SOLUTIONS LLCe8834b8ef191354e14af9ecbb9279f8a41caabca30bf0b8e522c37a16e94ee72
1894A076560001ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATELGM PHARMA325MG;50MG;40MG;30MGAB["AB"]2004-06-10Jun 10, 2004NoNoNoRXLGM PHARMA SOLUTIONS LLCb58aa52a1e8b12a670c24e8b93c122f27e5e305222f7f042e8330c5496a7b4a3
1895A075929001ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATENOSTRUM LABS INC325MG;50MG;40MG;30MGAB["AB"]2002-04-22Apr 22, 2002NoNoNoRXNOSTRUM LABORATORIES INC593111751b1c2b8ef7d00f95174c187b2dd4e0d7d1c69323c521d2a8c6ca8420
1896A204649001ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE;ORALCAPSULEORALBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATESTRIDES PHARMA325MG;50MG;40MG;30MGAB["AB"]2020-07-08Jul 8, 2020NoNoNoRXSTRIDES PHARMA GLOBAL PTE LTD1a871f32f532d8bff60e0eb66bb75fab7b90f7a4767a6fecf6c812d67c781e49
1897A078149001ASPIRIN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ASPIRIN AND CAFFEINENOSTRUM LABS INC325MG;50MG;40MG[]2007-06-13Jun 13, 2007NoNoNoDISCNNOSTRUM LABORATORIES INCd9f89a2ef1ada05c20a391e68bd55c1f8c2bace97c8df97f8e6e14ef857ea0be
1898A086231002ASPIRIN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALBUTALBITAL, ASPIRIN AND CAFFEINEWATSON LABS325MG;50MG;40MG[]1985-02-12Feb 12, 1985NoNoNoDISCNWATSON LABORATORIES INCd3c56ced7de22c498323f79e379fb727901754754372af68efaddab6c13ae91d
1899A075231001ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE;ORALCAPSULEORALBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATELGM PHARMA325MG;50MG;40MG;30MGAB["AB"]2001-11-30Nov 30, 2001NoNoNoRXLGM PHARMA SOLUTIONS LLCe0c37941da9677df73379e6e81facf0c1293a33314f09a593646550d58480c3c
1900A203335001ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE;ORALCAPSULEORALBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEMAYNE PHARMA INC325MG;50MG;40MG;30MGAB["AB"]2015-10-30Oct 30, 2015NoNoNoRXMAYNE PHARMA INC1ec9541b09ad82db97dd5a62d097d43627ae5c387d3e84c4b636f6deeccb9727
1901A074951001ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE;ORALCAPSULEORALBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATESTEVENS J325MG;50MG;40MG;30MGAB["AB"]1998-08-31Aug 31, 1998NoNoNoRXJEROME STEVENS PHARMACEUTICALS INC191909f2e9ae1afd8c0d28892987f225c71e03aed0baecafaf8b98372fe22ee0