← Snapshot 21

Orange Book snapshot 21: Products

Products page 65 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
3202A204989002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSCIEGEN PHARMS INC300MGAB["AB"]2016-02-18Feb 18, 2016NoNoNoRXSCIEGEN PHARMACEUTICALS INC41d427ca6ff85bf429732ee665bc420486bade885b8b37233778d0e20ca03e9e
3203A204989003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSCIEGEN PHARMS INC400MGAB["AB"]2016-02-18Feb 18, 2016NoNoNoRXSCIEGEN PHARMACEUTICALS INC83d6f77744bf3e37b66bdc87440f379eb57e5c5bde439a06dce9b559c9769a20
3204A211314001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSTRIDES PHARMA100MGAB["AB"]2018-10-16Oct 16, 2018NoNoNoRXSTRIDES PHARMA GLOBAL PTE LTD2fc131881b604ce2d5313aec57178c6d0f1ee86e02e3a56a3010e4de1f021e87
3205A211314002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSTRIDES PHARMA300MGAB["AB"]2018-10-16Oct 16, 2018NoNoNoRXSTRIDES PHARMA GLOBAL PTE LTD6baa11106b58f16f03d5282d12bbd45d0964307bb11cb86ec71a808b4a8d91b9
3206A211314003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSTRIDES PHARMA400MGAB["AB"]2018-10-16Oct 16, 2018NoNoNoRXSTRIDES PHARMA GLOBAL PTE LTDe2a988a59048c8dd5c0c22b494fe2dee4b11142292c371300a7767b795fde0ca
3207A076606001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSUN PHARM INDS LTD100MG[]2005-10-07Oct 7, 2005NoNoNoDISCNSUN PHARMACEUTICAL INDUSTRIES LTDa15d068fbde0e6ccd0b74417a86230df21030d31ad40be9fe1159f3968a3f40b
3208A077242001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSUN PHARM INDS LTD100MGAB["AB"]2006-08-24Aug 24, 2006NoNoNoRXSUN PHARMACEUTICAL INDUSTRIES LTDa620fbbe7f915118cca377c5f81bc418be249dd6a7a3526164d160f493fdaf6d
3209A076606002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSUN PHARM INDS LTD300MG[]2005-10-07Oct 7, 2005NoNoNoDISCNSUN PHARMACEUTICAL INDUSTRIES LTDf12cb38de91c51d3eafeaf3270891ef826b2eb0d19696f45d65ec0b7e9c153f4
3210A077242002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSUN PHARM INDS LTD300MGAB["AB"]2006-08-24Aug 24, 2006NoNoNoRXSUN PHARMACEUTICAL INDUSTRIES LTDa282e75cc7993c8bd0de3d5cc397e2ffb08cc62739e609fbdcb12f3aad6fe0de
3211A076606003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSUN PHARM INDS LTD400MG[]2005-10-07Oct 7, 2005NoNoNoDISCNSUN PHARMACEUTICAL INDUSTRIES LTD4502273715f48a802ee133d412b3d8f09b69aa477bbd753a5222da71c5916aaa
3212A077242003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSUN PHARM INDS LTD400MGAB["AB"]2006-08-24Aug 24, 2006NoNoNoRXSUN PHARMACEUTICAL INDUSTRIES LTD812975968f82a4b0dfc76b3201d5112c07b5b8e6f906efb41abab915c75c6e89
3213A076537001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSUN PHARM INDUSTRIES100MG[]2005-06-30Jun 30, 2005NoNoNoDISCNSUN PHARMACEUTICAL INDUSTRIES INC1f43d6a6955b8484137d92648974ffa0ab2b223c4d4a5fbcf5551300f4e3811a
3214A076537002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSUN PHARM INDUSTRIES300MG[]2005-06-30Jun 30, 2005NoNoNoDISCNSUN PHARMACEUTICAL INDUSTRIES INC8db111c65ca5003144c95a15bea7973fcf67dd96ccc82a2ee5d160d8fdda4b4b
3215A076537003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSUN PHARM INDUSTRIES400MG[]2005-06-30Jun 30, 2005NoNoNoDISCNSUN PHARMACEUTICAL INDUSTRIES INC0c399098997c3d7d41bbff2bf12e1232dbccf4a8d6f1ae454b9409b9fb2bc9ed
3216A077261001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINTARO100MGAB["AB"]2013-08-02Aug 2, 2013NoNoNoRXTARO PHARMACEUTICAL INDUSTRIES LTD3311771f42ffe325c89728c874828b1bb60111fc37d492a40eb567618636c772
3217A077261002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINTARO300MGAB["AB"]2013-08-02Aug 2, 2013NoNoNoRXTARO PHARMACEUTICAL INDUSTRIES LTDfd967dda2e9233f21863ea55b8221c36c3556e5b673eb0556442ec2d7d509438
3218A077261003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINTARO400MGAB["AB"]2013-08-02Aug 2, 2013NoNoNoRXTARO PHARMACEUTICAL INDUSTRIES LTD8efe5dff464aa6adb96bc1576da5d2db1694793a1dfb675e0403a457e7ff8a47
3219A075435001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINTEVA PHARMS100MG[]2004-10-08Oct 8, 2004NoNoNoDISCNTEVA PHARMACEUTICALS USA405b4da86d4eddd97b5a2d4722b667ead2dd8c4b438aeaf12262bfa3e9f8c55c
3220A075435002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINTEVA PHARMS300MG[]2004-10-08Oct 8, 2004NoNoNoDISCNTEVA PHARMACEUTICALS USA4b35ea2f850bf6c114e50fa83cce6493f0275bb801f5401abac64c8ed2e19870
3221A075435003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINTEVA PHARMS400MG[]2004-10-08Oct 8, 2004NoNoNoDISCNTEVA PHARMACEUTICALS USA05ba016be6b702cd7784a13122bc8d7974ba554f019a60ec1b23c64662976952
3222A075485003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINWATSON LABS100MG[]2007-05-11May 11, 2007NoNoNoDISCNWATSON LABORATORIES INCa56ef1bcd7f9217f9caaa447f3351a86f1ac591602f643381372a04b17bed82a
3223A075485002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINWATSON LABS300MG[]2007-05-11May 11, 2007NoNoNoDISCNWATSON LABORATORIES INC2c2eeb1d5fd9615714a5dd9f5af3e270b7ab4d4c26e8c2e3fdb4604fbe4eb69f
3224A075485001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINWATSON LABS400MG[]2007-05-11May 11, 2007NoNoNoDISCNWATSON LABORATORIES INC194864632d7bcb5e941ed4f25241c8fb7addb67377c3ae08c641bb836e2b9cea
3225A213603001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINZHEJIANG YONGTAI100MG[]2020-08-17Aug 17, 2020NoNoNoDISCNZHEJIANG YONGTAI PHARMACEUTICAL CO LTD94dc2511e6e3c53554919f9d4cf17084eb643e498c9909825e0814452d4c0944
3226A213603002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINZHEJIANG YONGTAI300MG[]2020-08-17Aug 17, 2020NoNoNoDISCNZHEJIANG YONGTAI PHARMACEUTICAL CO LTD090087b6b0ef364f885301c3f9374116b6cd24059f1b50de66473c47d6167c8c
3227A213603003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINZHEJIANG YONGTAI400MG[]2020-08-17Aug 17, 2020NoNoNoDISCNZHEJIANG YONGTAI PHARMACEUTICAL CO LTD32cad26a1dac547b3a45f079e29270bae60db219a44e54275bf2267f7fb8001b
3228N208623001MIGALASTAT HYDROCHLORIDECAPSULE;ORALCAPSULEORALGALAFOLDAMICUS THERAPS USEQ 123MG BASE[]2018-08-10Aug 10, 2018NoYesYesRXAMICUS THERAPEUTICS US INC2f5223386ad9aee8d2544647a8b71ca120a5bafe5d25a5f95e19306323b9419c
3229N020458001ZINC ACETATECAPSULE;ORALCAPSULEORALGALZINTEVAEQ 25MG ZINC[]1997-01-28Jan 28, 1997NoYesNoRXTEVA PHARMACEUTICALS USA INCe81b619962e6abda2518a656e4c807596cff20e05cda3a0b2be9575d3895654f
3230N020458002ZINC ACETATECAPSULE;ORALCAPSULEORALGALZINTEVAEQ 50MG ZINC[]1997-01-28Jan 28, 1997NoYesYesRXTEVA PHARMACEUTICALS USA INC0ac928ad81716036a7a9eda7ba2eb0f428ac6e39995534b7f2024d0bce07594f
3231A076457001GANCICLOVIRCAPSULE;ORALCAPSULEORALGANCICLOVIRRANBAXY LABS LTD250MG[]2003-06-27Jun 27, 2003NoNoNoDISCNRANBAXY LABORATORIES LTD014f45ec85b25918bf6d566b6644556b3359cad766ac88ded04c36879dfa3222
3232A076457002GANCICLOVIRCAPSULE;ORALCAPSULEORALGANCICLOVIRRANBAXY LABS LTD500MG[]2003-06-27Jun 27, 2003NoNoNoDISCNRANBAXY LABORATORIES LTD8f99ceb1bd6e949817617f0f885a5b4e230ea7416b5a56b6141b30b85371410e
3233N019188001CROMOLYN SODIUMCAPSULE;ORALCAPSULEORALGASTROCROMUCB INC100MG[]1989-12-22Dec 22, 1989NoNoNoDISCNUCB INC156048b8cabc73e0debdd745468020f08b2b94c2f28de93b80186ed5764f6db7
3234N213721001PRALSETINIBCAPSULE;ORALCAPSULEORALGAVRETOGENENTECH INC100MG[]2020-09-04Sep 4, 2020NoYesYesRXGENENTECH INC1686cee9daea62ab1d38fde1cd6d37ed0a62c16c0201b7d99885dfc74a83a083
3235A073466001GEMFIBROZILCAPSULE;ORALCAPSULEORALGEMFIBROZILMYLAN300MG[]1993-01-25Jan 25, 1993NoNoNoDISCNMYLAN PHARMACEUTICALS INC495fc6042f8bdf11562b83281abc94073c22981a90d6b9e9bcf36d2aea0de2f4
3236A072929001GEMFIBROZILCAPSULE;ORALCAPSULEORALGEMFIBROZILPUREPAC PHARM300MG[]1993-01-29Jan 29, 1993NoNoNoDISCNPUREPAC PHARMACEUTICAL COf554c13c51ec466228e1d6080f9745703a75199783089e81350ada7a6bb0120e
3237A213317001ETHINYL ESTRADIOL; NORETHINDRONE ACETATECAPSULE;ORALCAPSULEORALGEMMILYXIROMED0.02MG;1MGAB["AB"]2020-11-09Nov 9, 2020NoNoNoRXXIROMED PHARMA ESPANA SL419e45830a708fc3dc55fa5ba0876cc365b5806c469c52bf105bae10c6f03965
3238A065003001CYCLOSPORINECAPSULE;ORALCAPSULEORALGENGRAFABBVIE25MGAB1["AB1"]2000-05-12May 12, 2000NoNoNoRXABBVIE INC86583423c6823f82465d6722d20226ca5837d30b1b9a8822f3a788fd0ff0cb86
3239A065003002CYCLOSPORINECAPSULE;ORALCAPSULEORALGENGRAFABBVIE50MG[]2000-05-12May 12, 2000NoNoNoDISCNABBVIE INCdc525696cae645577a71eb4b7133cc704fbf3828297914ab0ea89039437244b1
3240A065003003CYCLOSPORINECAPSULE;ORALCAPSULEORALGENGRAFABBVIE100MGAB1["AB1"]2000-05-12May 12, 2000NoNoNoRXABBVIE INCead402cf7187a0e10275afc7127d179ef7bc7b64db37e2136302d99b03a15bf0
3241N020825001ZIPRASIDONE HYDROCHLORIDECAPSULE;ORALCAPSULEORALGEODONUPJOHNEQ 20MG BASEAB["AB"]2001-02-05Feb 5, 2001NoYesYesRXUPJOHN US 1 LLC66951314f0d105399b1b13e778516793215210169695dd0d84466df9dae98449
3242N020825002ZIPRASIDONE HYDROCHLORIDECAPSULE;ORALCAPSULEORALGEODONUPJOHNEQ 40MG BASEAB["AB"]2001-02-05Feb 5, 2001NoYesNoRXUPJOHN US 1 LLCadd5a7441419453953d181799e6d185cd14d3d914a89f973336c269043720974
3243N020825003ZIPRASIDONE HYDROCHLORIDECAPSULE;ORALCAPSULEORALGEODONUPJOHNEQ 60MG BASEAB["AB"]2001-02-05Feb 5, 2001NoYesNoRXUPJOHN US 1 LLC84f38494f55df4e2f5be57f110d03410d4b1e605ebe641738ea32ec67dc8f639
3244N020825004ZIPRASIDONE HYDROCHLORIDECAPSULE;ORALCAPSULEORALGEODONUPJOHNEQ 80MG BASEAB["AB"]2001-02-05Feb 5, 2001NoYesNoRXUPJOHN US 1 LLCff723342d10889ff57cfe380f777e56be443afa3555eb4f73fda01bebe539fb6
3245N022527002FINGOLIMOD HYDROCHLORIDECAPSULE;ORALCAPSULEORALGILENYANOVARTISEQ 0.25MG BASE[]2018-05-11May 11, 2018NoYesNoRXNOVARTIS PHARMACEUTICALS CORPb08f04c289cc20bbe118f7af2e45e734499150c7d4f788c68217c8ebb5c61708
3246N022527001FINGOLIMOD HYDROCHLORIDECAPSULE;ORALCAPSULEORALGILENYANOVARTISEQ 0.5MG BASEAB["AB"]2010-09-21Sep 21, 2010NoYesYesRXNOVARTIS PHARMACEUTICALS CORP35466dbda4d7ff3e7e33403b1a7c1c69f5e173680cd8ac7a80ebe18c73cb9b88
3247N021335001IMATINIB MESYLATECAPSULE;ORALCAPSULEORALGLEEVECNOVARTISEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]2001-05-10May 10, 2001NoYesNoDISCNNOVARTIS PHARMACEUTICALS CORPd181ec3a1add67d8c1afdce93d7f63a295636a8747d5bd0b73197f56e17755f8
3248N021335002IMATINIB MESYLATECAPSULE;ORALCAPSULEORALGLEEVECNOVARTISEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]2001-05-10May 10, 2001NoYesNoDISCNNOVARTIS PHARMACEUTICALS CORPdf2a46c3288fd41a2bf04e9126bc96518a63648d283c8eb1f129e0a9d088b194
3249N017588004LOMUSTINECAPSULE;ORALCAPSULEORALGLEOSTINECORDEN PHARMA5MG[]2014-12-19Dec 19, 2014NoYesNoDISCNCORDEN PHARMA LATINA SPA6bde7faee71a66625e7b819bd62cb81547d7252d1fe463d71217f9de24c5c2cc
3250N017588001LOMUSTINECAPSULE;ORALCAPSULEORALGLEOSTINECORDEN PHARMA10MG[]Approved Prior to Jan 1, 1982YesYesNoRXCORDEN PHARMA LATINA SPA15fd8916d4b580d82ec39bd13016d38849fad0f924b8e7a657e781c75a7be481
3251N017588002LOMUSTINECAPSULE;ORALCAPSULEORALGLEOSTINECORDEN PHARMA40MG[]Approved Prior to Jan 1, 1982YesYesNoRXCORDEN PHARMA LATINA SPA493fdc553858689bdb20e908698c704b9d991ca6a9e0245d0b6f883c622db7f9