← Snapshot 21

Orange Book snapshot 21: Products

Products page 79 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
3902A074132002NORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALNORTRIPTYLINE HYDROCHLORIDETEVAEQ 25MG BASEAB["AB"]1995-03-27Mar 27, 1995NoNoNoRXTEVA PHARMACEUTICALS USA INCdc858ee7750497ed9773d103d3131403061bb5ea6bf9deaee5cb3092bbd50a4d
3903A073667003NORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALNORTRIPTYLINE HYDROCHLORIDETEVAEQ 50MG BASE[]1996-04-11Apr 11, 1996NoNoNoDISCNTEVA PHARMACEUTICALS USA INC716ea28bcd69db1521c48890cf7b6bb4b07bf5b9a601e836b3c55380cd65f6db
3904A074132003NORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALNORTRIPTYLINE HYDROCHLORIDETEVAEQ 50MG BASEAB["AB"]1995-03-27Mar 27, 1995NoNoNoRXTEVA PHARMACEUTICALS USA INCfc96c8bc01e9eaa3115530f5e2af29d6b1ca23883788156d830513b4e1f21679
3905A073667004NORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALNORTRIPTYLINE HYDROCHLORIDETEVAEQ 75MG BASE[]1996-04-11Apr 11, 1996NoNoNoDISCNTEVA PHARMACEUTICALS USA INC46ef40fb61fb426656c67e84fca88d1fe551d0617ef43a0ed085378ce22cd76d
3906A074132004NORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALNORTRIPTYLINE HYDROCHLORIDETEVAEQ 75MG BASEAB["AB"]1995-03-27Mar 27, 1995NoNoNoRXTEVA PHARMACEUTICALS USA INCc57cd09b23aaa9c0ebd9225d2186ec7e6c961564a9e4d3bb68264c5e8cb25ee7
3907A213441001NORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALNORTRIPTYLINE HYDROCHLORIDEZYDUSEQ 10MG BASEAB["AB"]2021-02-24Feb 24, 2021NoNoNoRXZYDUS WORLDWIDE DMCC90f2acaec61126b41ca9d9cc1e3a8504168bf1d01f8b94400e9cc48570e7cff8
3908A213441002NORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALNORTRIPTYLINE HYDROCHLORIDEZYDUS EQ 25MG BASEAB["AB"]2021-02-24Feb 24, 2021NoNoNoRXZYDUS WORLDWIDE DMCC4da761c683c12ed3a6b6a75f179d3e73a794a34517348f6c199b07f661f49ed9
3909A213441003NORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALNORTRIPTYLINE HYDROCHLORIDEZYDUSEQ 50MG BASEAB["AB"]2021-02-24Feb 24, 2021NoNoNoRXZYDUS WORLDWIDE DMCCfbc5ead43c49a63c78c040d5c07ba0cf2361cbd527fbaa1f5e388eb4b3faa612
3910A213441004NORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALNORTRIPTYLINE HYDROCHLORIDEZYDUSEQ 75MG BASEAB["AB"]2021-02-24Feb 24, 2021NoNoNoRXZYDUS WORLDWIDE DMCC6db34ea34ee28812967baa290a1310670c42ef9619fcf47030f46d14d352bc90
3911N020680001RITONAVIRCAPSULE;ORALCAPSULEORALNORVIRABBOTT100MG[]1996-03-01Mar 1, 1996NoNoNoDISCNABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV2265e1cb6b2303dca16f6a3105b90cba644f76019c7fd9c26ffbc4126115cb10
3912N020945001RITONAVIRCAPSULE;ORALCAPSULEORALNORVIRABBVIE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1999-06-29Jun 29, 1999NoYesNoDISCNABBVIE INC578473253566ccd04cd826ec363986d56f13a195fe35c4f9984783df1ccd471c
3913N012928006LEVOPROPOXYPHENE NAPSYLATE ANHYDROUSCAPSULE;ORALCAPSULEORALNOVRADLILLYEQ 50MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNELI LILLY INDUSTRIES INC5426b07311df141c83acda9990090f5ae3ca65114068b561cd7f56f270cc2ad3
3914N012928004LEVOPROPOXYPHENE NAPSYLATE ANHYDROUSCAPSULE;ORALCAPSULEORALNOVRADLILLYEQ 100MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNELI LILLY INDUSTRIES INC6c119db71b1b728a33cb0286039fd5caebdcdefb838043e87503e7d596371b29
3915N021879001DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATECAPSULE;ORALCAPSULEORALNUEDEXTAAVANIR PHARMS20MG;10MGAB["AB"]2010-10-29Oct 29, 2010NoYesYesRXAVANIR PHARMACEUTICALS INCb05860f8d650dbffe393c3f4057d7a343fc850a4ac8cfb987216f155cce1bda4
3916N210793001PIMAVANSERIN TARTRATECAPSULE;ORALCAPSULEORALNUPLAZIDACADIA PHARMS INCEQ 34MG BASE[]2018-06-28Jun 28, 2018NoYesYesRXACADIA PHARMACEUTICALS INC869a69251bd71972ade8421788067c3c5bfc128fdec326d869b3dacb6b09430c
3917A087144001PHENTERMINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALOBESTIN-30FERNDALE LABS30MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNFERNDALE LABORATORIES INC6957237c12d8ee01af2a6e9d7c056b0b619a79b55b08d2b01fcbad4e9f8f7bb1
3918A087764001PHENTERMINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALOBY-TRIMSHIRE RICHWOOD30MG[]1982-03-18Mar 18, 1982NoNoNoDISCNSHIRE RICHWOOD INCc6ff93a1ef483cc17dd98d2b444ee196315fbdee94b8b5030ea7ecb808459740
3919N205266001SONIDEGIB PHOSPHATECAPSULE;ORALCAPSULEORALODOMZOSUN PHARMA GLOBALEQ 200MG BASE[]2015-07-24Jul 24, 2015NoYesYesRXSUN PHARMA GLOBAL FZE4e685803b17ef9dea48ad4817c6489fd32aeaf494af9b4f2ef0a30287fc37620
3920N205832001NINTEDANIB ESYLATECAPSULE;ORALCAPSULEORALOFEVBOEHRINGER INGELHEIMEQ 100MG BASE[]2014-10-15Oct 15, 2014NoYesNoRXBOEHRINGER INGELHEIM PHARMACEUTICALS INC33a616fccdd8f4a7ee80a23700e1a2ad5aa6bec047537fba43cbd28a9919d10a
3921N205832002NINTEDANIB ESYLATECAPSULE;ORALCAPSULEORALOFEVBOEHRINGER INGELHEIMEQ 150MG BASE[]2014-10-15Oct 15, 2014NoYesYesRXBOEHRINGER INGELHEIM PHARMACEUTICALS INC1d031a2be3a89a244387e5a197b107dbce7d6605d787f52bbe717d884fe92da0
3922A077742001FLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALCAPSULEORALOLANZAPINE AND FLUOXETINE HYDROCHLORIDEPAR PHARMEQ 25MG BASE;EQ 3MG BASEAB["AB"]2012-11-02Nov 2, 2012NoNoNoRXPAR PHARMACEUTICAL INC1bc0253a151a0cef5a3f83eeb37c44109822a16b0d142d3565f139ceb84bae9b
3923A077742002FLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALCAPSULEORALOLANZAPINE AND FLUOXETINE HYDROCHLORIDEPAR PHARMEQ 25MG BASE;EQ 6MG BASEAB["AB"]2012-11-02Nov 2, 2012NoNoNoRXPAR PHARMACEUTICAL INCc7c3a04e6ca092bc4c386ae38f7dc5efc638fb9767cc939e584eb3fbb386581c
3924A077742003FLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALCAPSULEORALOLANZAPINE AND FLUOXETINE HYDROCHLORIDEPAR PHARMEQ 25MG BASE;EQ 12MG BASEAB["AB"]2012-11-02Nov 2, 2012NoNoNoRXPAR PHARMACEUTICAL INCa4dad5236689b3c3326c76b19044751d998427a11b1441f68c5928ad00f38e2f
3925A077742004FLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALCAPSULEORALOLANZAPINE AND FLUOXETINE HYDROCHLORIDEPAR PHARMEQ 50MG BASE;EQ 6MG BASEAB["AB"]2012-11-02Nov 2, 2012NoNoNoRXPAR PHARMACEUTICAL INC9b7094aabdfd4595b90ccc2cfb24e28170fb8e90fa95ba033bbbb5bb00d22326
3926A077742005FLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALCAPSULEORALOLANZAPINE AND FLUOXETINE HYDROCHLORIDEPAR PHARMEQ 50MG BASE;EQ 12MG BASEAB["AB"]2012-11-02Nov 2, 2012NoNoNoRXPAR PHARMACEUTICAL INC96da889ed7f8002d8e3ba64dd4f44fa415ff5295a0f88c28aabbe0ec78a4e4be
3927A078901005FLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALCAPSULEORALOLANZAPINE AND FLUOXETINE HYDROCHLORIDESANDOZEQ 25MG BASE;EQ 3MG BASEAB["AB"]2012-11-16Nov 16, 2012NoNoNoRXSANDOZ INCc47392790b4c2ae5418fd5eadd870db357dc44fe92f2442a328d150a9de4e946
3928A078901001FLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALCAPSULEORALOLANZAPINE AND FLUOXETINE HYDROCHLORIDESANDOZEQ 25MG BASE;EQ 6MG BASEAB["AB"]2012-11-16Nov 16, 2012NoNoNoRXSANDOZ INC5f90bb4682069d07e28ae2b4d917c2dbaa36404b1cb51ee64c7f4d76e1c06cb6
3929A078901003FLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALCAPSULEORALOLANZAPINE AND FLUOXETINE HYDROCHLORIDESANDOZEQ 25MG BASE;EQ 12MG BASEAB["AB"]2012-11-16Nov 16, 2012NoNoNoRXSANDOZ INC8b6de1169aaa0dfd2453396f7f9af718c2d0852a014a9252872f16b9f5d4b9e1
3930A078901002FLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALCAPSULEORALOLANZAPINE AND FLUOXETINE HYDROCHLORIDESANDOZEQ 50MG BASE;EQ 6MG BASEAB["AB"]2012-11-16Nov 16, 2012NoNoNoRXSANDOZ INC01a8c77d6fd2bd747fbb5b30a06ae5b97d16247928d27eebab542df248cd6524
3931A078901004FLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALCAPSULEORALOLANZAPINE AND FLUOXETINE HYDROCHLORIDESANDOZEQ 50MG BASE;EQ 12MG BASEAB["AB"]2012-11-16Nov 16, 2012NoNoNoRXSANDOZ INC5d011265f7f035e6a667a129be37cb893e855b8b02d17d565401f582507de53a
3932A202074001FLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALCAPSULEORALOLANZAPINE AND FLUOXETINE HYDROCHLORIDETEVA PHARMSEQ 25MG BASE;EQ 3MG BASEAB["AB"]2013-03-25Mar 25, 2013NoNoNoRXTEVA PHARMACEUTICALS USA0a0c9c7442e093996878df2f800928f3b15fb1b3f6c6a484977a68e25c43c412
3933A077528001FLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALCAPSULEORALOLANZAPINE AND FLUOXETINE HYDROCHLORIDETEVA PHARMSEQ 25MG BASE;EQ 6MG BASEAB["AB"]2012-06-19Jun 19, 2012NoNoNoRXTEVA PHARMACEUTICALS USAf851c72293240d74b2a84ffd9a0647cbf20584c5c487fdbd396cd6d04b0b485a
3934A077528002FLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALCAPSULEORALOLANZAPINE AND FLUOXETINE HYDROCHLORIDETEVA PHARMSEQ 25MG BASE;EQ 12MG BASEAB["AB"]2012-06-19Jun 19, 2012NoNoNoRXTEVA PHARMACEUTICALS USA0007fd1352d34fc6ce57bcae0b4f1f71f3a765b51a341bb663f6426fb60ca7a4
3935A077528003FLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALCAPSULEORALOLANZAPINE AND FLUOXETINE HYDROCHLORIDETEVA PHARMSEQ 50MG BASE;EQ 6MG BASEAB["AB"]2012-06-19Jun 19, 2012NoNoNoRXTEVA PHARMACEUTICALS USA5cdb57a3946b1f670c48f624dce09e5674d2fa8ebb2ad4ef95d27f8cd669270c
3936A077528004FLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALCAPSULEORALOLANZAPINE AND FLUOXETINE HYDROCHLORIDETEVA PHARMSEQ 50MG BASE;EQ 12MG BASEAB["AB"]2012-06-19Jun 19, 2012NoNoNoRXTEVA PHARMACEUTICALS USAe72632c6ae681973f10c4d59ebe96bc00dfeb4481e30cb616041bdaf1a903456
3937N205123001SIMEPREVIR SODIUMCAPSULE;ORALCAPSULEORALOLYSIOJANSSEN PRODSEQ 150MG BASE[]2013-11-22Nov 22, 2013NoYesNoDISCNJANSSEN PRODUCTS LP616d395bd1e97bd73405d8240f2d7d24a6e5cdeb16be1193b5d459ffefc77d64
3938A204940001OMEGA-3-ACID ETHYL ESTERSCAPSULE;ORALCAPSULEORALOMEGA-3-ACID ETHYL ESTERSAMNEAL PHARMS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSAB["AB"]2015-11-27Nov 27, 2015NoNoNoRXAMNEAL PHARMACEUTICALS OF NEW YORK LLC32b61b8090ca3be9f69a1261eeb68345b9859da7948c4872e59cae3d2e48effb
3939A090973001OMEGA-3-ACID ETHYL ESTERSCAPSULE;ORALCAPSULEORALOMEGA-3-ACID ETHYL ESTERSAPOTEX1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSAB["AB"]2014-09-30Sep 30, 2014NoNoNoRXAPOTEX INCf655bb3aace8963efb318fa4cea2ab752d040af23bc50cc87e646162a6168f9e
3940A207420001OMEGA-3-ACID ETHYL ESTERSCAPSULE;ORALCAPSULEORALOMEGA-3-ACID ETHYL ESTERSASCENT PHARMS INC1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSAB["AB"]2019-02-25Feb 25, 2019NoNoNoRXASCENT PHARMACEUTICALS INCbe0e46e7c45cbed725e73d1b65c43d698cb7bd04f9ccd3c9c56a6391aa11ddbe
3941A206455001OMEGA-3-ACID ETHYL ESTERSCAPSULE;ORALCAPSULEORALOMEGA-3-ACID ETHYL ESTERSBIONPHARMA INC1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSAB["AB"]2019-08-07Aug 7, 2019NoNoNoRXBIONPHARMA INC6a2acb615e74ac29003bb20c1739742b927ab0096b833c3551f2b6cff02a552f
3942A211979001OMEGA-3-ACID ETHYL ESTERSCAPSULE;ORALCAPSULEORALOMEGA-3-ACID ETHYL ESTERSCSPC-NBP PHARM1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSAB["AB"]2020-05-12May 12, 2020NoNoNoRXCSPC-NBP PHARMACEUTICAL CO LTDc5617a352b7518795bdaac8a0fef11740e2de42b13216b75d3eeaf2f486eec8c
3943A212504001OMEGA-3-ACID ETHYL ESTERSCAPSULE;ORALCAPSULEORALOMEGA-3-ACID ETHYL ESTERSGLW1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSAB["AB"]2020-08-19Aug 19, 2020NoNoNoRXGLW PHARMA GMBHce09b2713bf750bed47c2903c7d162b638a03cc79395828b09b58bf2a68d903c
3944A091018001OMEGA-3-ACID ETHYL ESTERSCAPSULE;ORALCAPSULEORALOMEGA-3-ACID ETHYL ESTERSPAR PHARM INC1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS[]2014-06-24Jun 24, 2014NoNoNoDISCNPAR PHARMACEUTICAL INC650d722545f0a5efb27930112f2de0b5bc19847f3e9275b3c1e7655f4af6637f
3945A210093001OMEGA-3-ACID ETHYL ESTERSCAPSULE;ORALCAPSULEORALOMEGA-3-ACID ETHYL ESTERSPURACAP PHARM LLC1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSAB["AB"]2020-06-15Jun 15, 2020NoNoNoRXPURACAP PHARMACEUTICAL LLCf9e52d09b9d5a0eb101cdf2ea13ef7b15d81cb6f9d86018b57621b269dee117d
3946A211355001OMEGA-3-ACID ETHYL ESTERSCAPSULE;ORALCAPSULEORALOMEGA-3-ACID ETHYL ESTERSSOFGEN PHARMS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSAB["AB"]2019-07-10Jul 10, 2019NoNoNoRXSOFGEN PHARMACEUTICALS LLC6301443bb5ca4b00a44a866fe17cd7f67503f577d0178c9323607e2059ea2226
3947A203893001OMEGA-3-ACID ETHYL ESTERSCAPSULE;ORALCAPSULEORALOMEGA-3-ACID ETHYL ESTERSSTRIDES PHARMA1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSAB["AB"]2017-09-19Sep 19, 2017NoNoNoRXSTRIDES PHARMA GLOBAL PTE LTD9a6b223ce3260e288f9bdfb43230b60a27e68bca474bf4a0f92b9dd39f66f215
3948A210834001OMEGA-3-ACID ETHYL ESTERSCAPSULE;ORALCAPSULEORALOMEGA-3-ACID ETHYL ESTERSSUN PHARM1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSAB["AB"]2020-01-09Jan 9, 2020NoNoNoRXSUN PHARMACEUTICAL INDUSTRIES LTDd49fee60610bb4138e693a223583c9188cd36d245deb203108ed7a366fc23fa4
3949A091028001OMEGA-3-ACID ETHYL ESTERSCAPSULE;ORALCAPSULEORALOMEGA-3-ACID ETHYL ESTERSTEVA PHARMS USA1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSAB["AB"]2014-04-07Apr 7, 2014NoNoNoRXTEVA PHARMACEUTICALS USA6298f2416be7b829b77d006f8c04b1f8dcdb3b4cfb103dc55d2ae0db7ac0e12e
3950A210107001OMEGA-3-ACID ETHYL ESTERSCAPSULE;ORALCAPSULEORALOMEGA-3-ACID ETHYL ESTERSZYDUS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS[]2019-06-14Jun 14, 2019NoNoNoDISCNZYDUS WORLDWIDE DMCCa128071c116dff8f27e44d70958a22ee99766212051af64752c0dd571e4df89d
3951A204228001OMEPRAZOLE; SODIUM BICARBONATECAPSULE;ORALCAPSULEORALOMEPRAZOLE AND SODIUM BICARBONATEAJANTA PHARMA LTD20MG;1.1GMAB["AB"]2016-07-15Jul 15, 2016NoNoNoRXAJANTA PHARMA LTD895b2e0c4cd7570456c415f5f631b3f66d28957b2d8b600958fe1a1b3568e24c