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← Snapshot 21

Orange Book snapshot 21: Products

Products page 10 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
452A200913002CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDMYLAN PHARMS INCEQ 135MG FENOFIBRIC ACID[]2013-03-25Mar 25, 2013NoNoNoDISCNMYLAN PHARMACEUTICALS INC3ef4363808eea75781cfd8c83bcb281fe3d799fa0423411fcbe734c8656879ed
453A210469001CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDTWI PHARMSEQ 45MG FENOFIBRIC ACIDAB["AB"]2019-07-05Jul 5, 2019NoNoNoRXTWI PHARMACEUTICALS INCf9d2caafa62c4f24609cb8c0abc3f094251c63a971d61e0353d30c5cfcffbbf7
454A210469002CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDTWI PHARMSEQ 135MG FENOFIBRIC ACIDAB["AB"]2019-07-05Jul 5, 2019NoNoNoRXTWI PHARMACEUTICALS INCd908210eb3bea5cf9501418c420af7d72f51d67066a4f5998a9db00e79a4bdd7
455A212562001CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDYICHANG HUMANWELLEQ 45MG FENOFIBRIC ACIDAB["AB"]2020-12-23Dec 23, 2020NoNoNoRXYICHANG HUMANWELL PHARMACEUTICAL CO LTD4f418e19a1cea4549a30be8aab0e3fd2936de5c9d08d6d42475d6645bc354905
456A212562002CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDYICHANG HUMANWELLEQ 135MG FENOFIBRIC ACIDAB["AB"]2020-12-23Dec 23, 2020NoNoNoRXYICHANG HUMANWELL PHARMACEUTICAL CO LTD0f9e5d60e88c974ab0459c2f43869b2fb4f2934d67cad01c463d3a0afa90462e
457A207873001MESALAMINECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALMESALAMINETEVA PHARMS USA400MGAB["AB"]2019-05-09May 9, 2019NoNoNoRXTEVA PHARMACEUTICALS USA INC2bcdb81b97d479147d89a41feabbcbae7d67b1fad7e4ce57c6edb1b74f2f0eee
458N208232001OCTREOTIDE ACETATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALMYCAPSSACHIASMAEQ 20MG BASE[]2020-06-26Jun 26, 2020NoYesYesRXCHIASMA INC6b900adbeb489d2dfdd33970eb2b6936174f56fccd52d495c5aa476449628dcc
459N204655001ESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALNEXIUM 24HRASTRAZENECA LPEQ 20MG BASE[]2014-03-28Mar 28, 2014NoYesYesOTCASTRAZENECA LP853afbd00566b6e7927f5c49aa3da69605aa02ddb17ca4969c40ddd05d077f20
460A078878001OMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALOMEPRAZOLE MAGNESIUMDR REDDYS LABS LTDEQ 20MG BASE[]2009-06-05Jun 5, 2009NoNoYesOTCDR REDDYS LABORATORIES LTDfeb29f8811de1088ddde329606741ba30be3b16e811269a9b151f86186a927b2
461A210593001OMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALOMEPRAZOLE MAGNESIUMSPILEQ 20MG BASE[]2018-07-20Jul 20, 2018NoNoNoOTCSUN PHARMA INDUSTRIES LTDc086ff63b909add116f4f27622ddf41ca855717ddcd24252fd33158ff54aa396
462N203389001CYSTEAMINE BITARTRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALPROCYSBIHORIZON PHARMA USAEQ 25MG BASE[]2013-04-30Apr 30, 2013NoYesNoRXHORIZON PHARMA USA INC548d7ee6be1f221ab0a333aadac4b8b7836c053883bed8158896e744e8969503
463N203389002CYSTEAMINE BITARTRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALPROCYSBIHORIZON PHARMA USAEQ 75MG BASE[]2013-04-30Apr 30, 2013NoYesYesRXHORIZON PHARMA USA INC05bffecf21b01e1ddb1d73459a0747c298622deedd6947f0b0a99b7351590382
464N022152001VALPROIC ACIDCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALSTAVZORBIONPHARMA INC125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]2008-07-29Jul 29, 2008NoYesNoDISCNBIONPHARMA INC0c7f97605830ac1306a482b41b6efb2cd4421f47749d65a47268860604982e93
465N022152002VALPROIC ACIDCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALSTAVZORBIONPHARMA INC250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]2008-07-29Jul 29, 2008NoYesNoDISCNBIONPHARMA INCf2994a77a8bc52c1d3ec8868843037b0f2536d3ec5ad69390d2cfee712c2ff55
466N022152003VALPROIC ACIDCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALSTAVZORBIONPHARMA INC500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]2008-07-29Jul 29, 2008NoYesNoDISCNBIONPHARMA INC09d0fc7391c5b05a120a1a98e9ea93b5c461a923b2d26d808f7cc1dd3198c128
467N213004001AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTINCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALTALICIAREDHILL250MG;EQ 10MG BASE;12.5MG[]2019-11-01Nov 1, 2019NoYesYesRXREDHILL BIOPHARMA LTDba777017910497d6ec90ecd34a04968fff709e0262f874d283e75487474aed2f
468N204063001DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALTECFIDERABIOGEN IDEC INC120MGAB["AB"]2013-03-27Mar 27, 2013NoYesNoRXBIOGEN IDEC INCf9253b77a8ab7190165c6680061cab4a6f48e4d48a9d7d280806b29bd8e258c9
469N204063002DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALTECFIDERABIOGEN IDEC INC240MGAB["AB"]2013-03-27Mar 27, 2013NoYesYesRXBIOGEN IDEC INC688b9e4a14c001bf70d69cb635c264700fcee665658ac0e020a8f1a2dd74366a
470N022224001CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALTRILIPIXABBVIEEQ 45MG FENOFIBRIC ACIDAB["AB"]2008-12-15Dec 15, 2008NoYesNoRXABBVIE INC1ff050bf87f3b0277e9bbdc7aaf4065f866f2b2048f8e5a5421c0fb50dfad549
471N022224002CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALTRILIPIXABBVIEEQ 135MG FENOFIBRIC ACIDAB["AB"]2008-12-15Dec 15, 2008NoYesYesRXABBVIE INCea2d57256647351ede4f7be76ef36dd01b80ea3364dff63a8f9188cbd0ac2d45
472N211855001DIROXIMEL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALVUMERITYBIOGEN231MG[]2019-10-29Oct 29, 2019NoYesYesRXBIOGENa0a841d72dc29dd058e8a299aded300aea7598b6e7c9e9fd3c3be8338a92bf79
473A207659001ACETAZOLAMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALACETAZOLAMIDEACCORD HLTHCARE500MG[]2018-10-18Oct 18, 2018NoNoNoDISCNACCORD HEALTHCARE INC28ad435b88b96f4c49aa3edd7dd5535611b833924aaf99e9b55b74424b76b927
474A210423001ACETAZOLAMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALACETAZOLAMIDEALEMBIC PHARMS LTD500MGAB["AB"]2019-02-19Feb 19, 2019NoNoNoRXALEMBIC PHARMACEUTICALS LTD7e10ce0a7204bfd4fc28437f65fd5ba3a8e6f14218333a4243128d2cda78435b
475A205301001ACETAZOLAMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALACETAZOLAMIDECADILA500MGAB["AB"]2019-01-16Jan 16, 2019NoNoNoRXCADILA HEALTHCARE LTDe170331d50578466ded1afc9e9fc7b05ab64b79a2a3efc2cc882675ca8e6eab0
476A040904001ACETAZOLAMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALACETAZOLAMIDEHERITAGE PHARMA500MGAB["AB"]2008-12-10Dec 10, 2008NoNoNoRXHERITAGE PHARMA LABS INC4b24dc56af9aab91071e3b1c8f061b3fa817282194f1921150142f167caed63d
477A090779001ACETAZOLAMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALACETAZOLAMIDEHERITAGE PHARMS INC500MGAB["AB"]2011-07-14Jul 14, 2011NoNoYesRXHERITAGE PHARMACEUTICALS INCe4b6cf44b13da565f901d5b1e682143f313bf702dc74d34cfcfb6ed4c260f527
478A207401001ACETAZOLAMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALACETAZOLAMIDEMICRO LABS LTD INDIA500MGAB["AB"]2020-10-01Oct 1, 2020NoNoNoRXMICRO LABS LTD INDIAa0f23a21b212d40b52a202b044eafde05e26546fc85bdc145a36e1505804ffa7
479A203917001ACETAZOLAMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALACETAZOLAMIDEMYLAN500MG[]2019-06-18Jun 18, 2019NoNoNoDISCNMYLAN PHARMACEUTICALS INC2b041d745a2cb2edde8be2dfb77c6e743873c4df0a52c5339ed3c8c806583750
480A204691001ACETAZOLAMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALACETAZOLAMIDENOSTRUM LABS INC500MGAB["AB"]2016-03-29Mar 29, 2016NoNoNoRXNOSTRUM LABORATORIES INC978971c71bb951f4f77a99a7cbdfae310762f3e43b96b43f023edc6cd9f0ad15
481A203434001ACETAZOLAMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALACETAZOLAMIDENOVAST LABS500MGAB["AB"]2016-09-30Sep 30, 2016NoNoNoRXNOVAST LABORATORIES LTD6c2f544083fb15045a0cfc99353241e856483c092c7b1c0236912b9219633584
482N018996001PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALACTIFEDGLAXOSMITHKLINE120MG;5MG[]1985-06-17Jun 17, 1985NoNoNoDISCNGLAXOSMITHKLINEe9b0d960f5e278dd199c260b65aca127dca1811937de6bbc51a84870429adf84
483N021303001AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALADDERALL XR 10TAKEDA PHARMS USA2.5MG;2.5MG;2.5MG;2.5MGAB["AB"]2001-10-11Oct 11, 2001NoYesNoRXTAKEDA PHARMACEUTICALS USA INCc5f2dce02d22ed3b8c575e7694ec6a642947907c883c18eba381ce137383f0d8
484N021303006AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALADDERALL XR 15TAKEDA PHARMS USA3.75MG;3.75MG;3.75MG;3.75MGAB["AB"]2002-05-22May 22, 2002NoYesNoRXTAKEDA PHARMACEUTICALS USA INC8cbc124a6df20da31ef5fac2e15576497fc5345539750db4813ac2b0ea9928c9
485N021303002AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALADDERALL XR 20TAKEDA PHARMS USA5MG;5MG;5MG;5MGAB["AB"]2001-10-11Oct 11, 2001NoYesNoRXTAKEDA PHARMACEUTICALS USA INC3922fa98b9d170ec56ef97f898682b933134d89adc9b41d0f875b228889e3f44
486N021303004AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALADDERALL XR 25TAKEDA PHARMS USA6.25MG;6.25MG;6.25MG;6.25MGAB["AB"]2002-05-22May 22, 2002NoYesNoRXTAKEDA PHARMACEUTICALS USA INCa47cdbbf1c7c69b58e2f77f61706c9caa5314c03377b373f30245630dc49b03b
487N021303003AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALADDERALL XR 30TAKEDA PHARMS USA7.5MG;7.5MG;7.5MG;7.5MGAB["AB"]2001-10-11Oct 11, 2001NoYesYesRXTAKEDA PHARMACEUTICALS USA INC4b27e805aa040b26738763c52d4b429ffe13642b34ad9ea876df0059e583948f
488N021303005AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALADDERALL XR 5TAKEDA PHARMS USA1.25MG;1.25MG;1.25MG;1.25MGAB["AB"]2002-05-22May 22, 2002NoYesNoRXTAKEDA PHARMACEUTICALS USA INC7d82ac051f217e0abac72d5a349af930e9deef8173308acf6e90aa81fdcfcabe
489N212038001METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALADHANSIA XRPURDUE PHARMA LP25MG[]2019-02-27Feb 27, 2019NoYesNoRXPURDUE PHARMA LP6bd18ea5f92e3ac760650423a42857ca95702affc7b6f9ede1c8c6158af25a8f
490N212038002METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALADHANSIA XRPURDUE PHARMA LP35MG[]2019-02-27Feb 27, 2019NoYesNoRXPURDUE PHARMA LP448de6a1c6aeb6e9f11db2154fd1466e01d203be51aae1ef1828bf9812e8eff0
491N212038003METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALADHANSIA XRPURDUE PHARMA LP45MG[]2019-02-27Feb 27, 2019NoYesNoRXPURDUE PHARMA LP3dbab60c4a7e3736c6a7e55001eeeb2d07376150a17ceff89cd4e7f7bf1bc6af
492N212038004METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALADHANSIA XRPURDUE PHARMA LP55MG[]2019-02-27Feb 27, 2019NoYesNoRXPURDUE PHARMA LPd31b8d135f863779483522d02e60f092e4d0313ce3c60161c29ce3fa1e5045a7
493N212038005METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALADHANSIA XRPURDUE PHARMA LP70MG[]2019-02-27Feb 27, 2019NoYesNoRXPURDUE PHARMA LP43dcc5e7828d8c59d3ee82f1a4059c02cf939b316767245d8f0c28d73abf2d75
494N212038006METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALADHANSIA XRPURDUE PHARMA LP85MG[]2019-02-27Feb 27, 2019NoYesYesRXPURDUE PHARMA LPaae10304f070100cea66e947ad3a7b8b16a0d269956a310065a7b3dd0e4e50b9
495A085075003THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAEROLATE IIIFLEMING PHARMS65MG[]1986-11-24Nov 24, 1986NoNoNoDISCNFLEMING AND CO PHARMACEUTICALS INCca5939ab6d4d8ef6ee62d1bed2cf6fa9e7b478a0477ea80a3a6948fe1fe8889b
496A085075002THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAEROLATE JRFLEMING PHARMS130MG[]1986-11-24Nov 24, 1986NoNoNoDISCNFLEMING AND CO PHARMACEUTICALS INC38f3f52d4059973641e8e878716fdd4234dccc1a4252d88fa567f8ab1670ce08
497A085075001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAEROLATE SRFLEMING PHARMS260MG[]1986-11-24Nov 24, 1986NoNoNoDISCNFLEMING AND CO PHARMACEUTICALS INC1f3515782b2dcd38156890ba64d78c5d7e1be1a915d76e22b0fdbca15ffe0170
498N020884001ASPIRIN; DIPYRIDAMOLECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAGGRENOXBOEHRINGER INGELHEIM25MG;200MGAB["AB"]1999-11-22Nov 22, 1999NoYesYesRXBOEHRINGER INGELHEIM PHARMACEUTICALS INCae2298dbb9eeb87009069629c99524c9d42acc4cf641b384f1f205d4bfb82cfc
499N021777001CYCLOBENZAPRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAMRIXTEVA PHARMS INTL15MGAB["AB"]2007-02-01Feb 1, 2007NoYesNoRXTEVA PHARMACEUTICALS INTERNATIONAL GMBH8efa1d89eecd8b17dc4e4ca170170eff5680688088d6210dab200328286c6ca7
500N021777002CYCLOBENZAPRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAMRIXTEVA PHARMS INTL30MGAB["AB"]2007-02-01Feb 1, 2007NoYesYesRXTEVA PHARMACEUTICALS INTERNATIONAL GMBHdc844c8e9ead90bbd1630cae8075b652f5177ea3d1184b5442757911d3d7e386
501N022301001MESALAMINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAPRISOVALEANT PHARMS INTL375MGAB["AB"]2008-10-31Oct 31, 2008NoYesYesRXVALEANT PHARMACEUTICALS INTERNATIONAL5be0a3c7f4a5d128d0d959a1a83c6b3ff68b0139156b45c078140d7edc0cac0b