← Snapshot 21

Orange Book snapshot 21: Products

Products page 9 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
402A210500001DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEHETERO LABS LTD III120MGAB["AB"]2020-09-24Sep 24, 2020NoNoNoRXHETERO LABS LTD UNIT IIIc5dc3bb47ebef0e15657122ca1a9a4c454782b3c5155cf43dcf6d86661014440
403A210500002DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEHETERO LABS LTD III240MGAB["AB"]2020-09-24Sep 24, 2020NoNoNoRXHETERO LABS LTD UNIT IIIa332973fd81d37d2ae32e76657b6865c615f0c6a5b9c0c0ecfcedd6c4997fb9c
404A210226001DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATELUPIN ATLANTIS120MGAB["AB"]2020-10-05Oct 5, 2020NoNoNoRXLUPIN ATLANTIS HOLDINGS SA5fd41988eb143e57d3ad6d07b4fe85fd3c9f742e11878725be82a5ae31fb74fb
405A210226002DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATELUPIN ATLANTIS240MGAB["AB"]2020-10-05Oct 5, 2020NoNoNoRXLUPIN ATLANTIS HOLDINGS SAa50b64fafba9dc408f203c97c2d1c1aea32cc6f8034ffdca306bd7dee7a14e85
406A210460001DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEMSN120MGAB["AB"]2020-09-24Sep 24, 2020NoNoNoRXMSN LABORATORIES PRIVATE LTD960be617dc001b0959a2f673fe79132dffb347561881dd097e73702ee6c90ee7
407A210460002DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEMSN240MGAB["AB"]2020-09-24Sep 24, 2020NoNoNoRXMSN LABORATORIES PRIVATE LTD0e098066282be12908007403849a049009caa8d2cee3d2e04a40123feaf38174
408A210531001DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEMYLAN120MGAB["AB"]2020-08-17Aug 17, 2020NoNoNoRXMYLAN PHARMACEUTICALS INC42faf993eaca42a7044e5d5d5f98e3dbea2accd248d5a43fbe8fd1df5e1b3202
409A210531002DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEMYLAN240MGAB["AB"]2020-08-17Aug 17, 2020NoNoNoRXMYLAN PHARMACEUTICALS INC7580f43653871eba5ef2646864425383164143f786f912d05ba83eda55778d29
410A210436001DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEPHARMATHEN120MGAB["AB"]2021-03-26Mar 26, 2021NoNoNoRXPHARMATHEN SA9c3bd4bdce0116e927eb1b3a9936d2adb602733553697d7befc2ad99d59f17bb
411A210436002DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEPHARMATHEN240MGAB["AB"]2021-03-26Mar 26, 2021NoNoNoRXPHARMATHEN SAaca6d6845e196602b9599d9e5eb26cc5818e26605b00a128153ddab4dfd4f0b2
412A210382001DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATETWI PHARMS120MGAB["AB"]2020-10-14Oct 14, 2020NoNoNoRXTWI PHARMACEUTICALS INCa9b874eb812894d03c92579d841f5546eff38fef453b2f4e3e8ac042e9fb0dbd
413A210382002DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATETWI PHARMS240MGAB["AB"]2020-10-14Oct 14, 2020NoNoNoRXTWI PHARMACEUTICALS INC6155b49773456552f2c0db80c6cef212dd82f67a75e07fdb4f3135bf96d5b910
414A210538001DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEZYDUS PHARMS120MG[]2020-09-24Sep 24, 2020NoNoNoDISCNZYDUS PHARMACEUTICALS USA INC8ce9f83e48ed9c26a9a057806f1f7740561b7757d22d75247e8ec267d3b508db
415A210538002DIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDIMETHYL FUMARATEZYDUS PHARMS240MG[]2020-09-24Sep 24, 2020NoNoNoDISCNZYDUS PHARMACEUTICALS USA INC125558a6d523ac0f62037212a5da445c65fdcdca2f458d03b896db083452a65a
416N050582002DOXYCYCLINE HYCLATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDORYXMAYNE PHARMA INTLEQ 75MG BASE[]2001-08-13Aug 13, 2001NoYesNoDISCNMAYNE PHARMA INTERNATIONAL FAULDING PHARMb216ec130d9c6da7221cce45b19b886dbc09fb92bde33f12ed2d1bf580cf6f46
417N050582001DOXYCYCLINE HYCLATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDORYXMAYNE PHARMA INTLEQ 100MG BASE[]1985-07-22Jul 22, 1985NoYesNoDISCNMAYNE PHARMA INTERNATIONAL FAULDING PHARM4b236a9acdfd5565e10b2ad517720084e1439d2d86f7197fb57df2fd5184ac4d
418A062653001DOXYCYCLINE HYCLATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDORYXWARNER CHILCOTTEQ 100MG BASE[]1985-10-30Oct 30, 1985NoNoNoDISCNWARNER CHILCOTT BERMUDA LTD9820c20bbaa0db2120f6c5a608c49f1c33020e409e1e15c4923aef7bee99b877
419A065281001DOXYCYCLINE HYCLATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDOXYCYCLINE HYCLATEMEDICISEQ 75MG BASE[]2005-12-21Dec 21, 2005NoNoNoDISCNMEDICIS PHARMACEUTICAL CORP2b0bd318cc460fbfab0cdc88bddcae855629f0af83c956d678e2e98892c9c63d
420A065281002DOXYCYCLINE HYCLATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDOXYCYCLINE HYCLATEMEDICISEQ 100MG BASE[]2005-12-21Dec 21, 2005NoNoNoDISCNMEDICIS PHARMACEUTICAL CORP3e9fd4d4fff2a68af1cdda23ec9ae7dc98fde9ef80992e9229211cd87da4584a
421N212516001DULOXETINE HYDROCHLORIDECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDRIZALMA SPRINKLESUN PHARMA GLOBALEQ 20MG BASE[]2019-07-19Jul 19, 2019NoYesNoRXSUN PHARMA GLOBAL FZEd132933c657cbf7131be8ac4710b5b17e58cf2b8943552062bc5e245696cd31b
422N212516002DULOXETINE HYDROCHLORIDECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDRIZALMA SPRINKLESUN PHARMA GLOBALEQ 30MG BASE[]2019-07-19Jul 19, 2019NoYesNoRXSUN PHARMA GLOBAL FZE274159ef90a2f0eb65940d5e5ae857eff19085bc9255ddfde2eca4694095f706
423N212516003DULOXETINE HYDROCHLORIDECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDRIZALMA SPRINKLESUN PHARMA GLOBALEQ 40MG BASE[]2019-07-19Jul 19, 2019NoYesNoRXSUN PHARMA GLOBAL FZE35dd68b5691270b0ac655197119b0465330cc6970f8f208ad84a91d9891c918c
424N212516004DULOXETINE HYDROCHLORIDECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALDRIZALMA SPRINKLESUN PHARMA GLOBALEQ 60MG BASE[]2019-07-19Jul 19, 2019NoYesYesRXSUN PHARMA GLOBAL FZE3fefd9c76ffe9a6a9f3427ed34b1863c319c86c330fc8cef5a30183e6dbd4dd4
425A209716001ESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALESOMEPRAZOLE MAGNESIUMAMNEAL PHARMS NYEQ 20MG BASE[]2019-06-05Jun 5, 2019NoNoNoOTCAMNEAL PHARMACEUTICALS OF NY LLC51782df1c9280cf1c77241bea81bc0c3a4fb67e940a07ac9df11e1c0719aaa56
426A209339001ESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALESOMEPRAZOLE MAGNESIUMAUROBINDO PHARMA LTDEQ 20MG BASE[]2017-10-16Oct 16, 2017NoNoNoOTCAUROBINDO PHARMA LTD649bda53b89eba08091ff5a4e1357da9eb371135557ebac039e64a0c2f14140c
427A207673001ESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALESOMEPRAZOLE MAGNESIUMDR REDDYS LABS LTDEQ 20MG BASE[]2018-05-15May 15, 2018NoNoNoOTCDR REDDYS LABORATORIES LTDd87a9546f03d2802622d1a2fe28670623295b5e6826b3abc71d00905b99ff55e
428A208939001ESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALESOMEPRAZOLE MAGNESIUMHETERO LABS LTD IIIEQ 20MG BASE[]2020-05-28May 28, 2020NoNoNoOTCHETERO LABS LTD UNIT III22935b5f2bea9d07639fde829d0ab1b7f071783d96ab2d267e8e84c337f3198a
429A212507001ESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALESOMEPRAZOLE MAGNESIUMHETERO LABS LTD IIIEQ 20MG BASE[]2020-06-02Jun 2, 2020NoNoNoOTCHETERO LABS LTD UNIT IIIe21c35b71b6e425c6d603851a5db3bfd3d4a7a290d0e5247ff95409814c4ee88
430A212376001ESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALESOMEPRAZOLE MAGNESIUMMYLANEQ 20MG BASE[]2019-10-16Oct 16, 2019NoNoNoDISCNMYLAN PHARMACEUTICALS INCb15ab1c0e826867f77ad6c3ee462f27cb2c04e1988dfebca95acda6a118a427e
431A207193001ESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALESOMEPRAZOLE MAGNESIUMPERRIGO R AND DEQ 20MG BASE[]2017-08-18Aug 18, 2017NoNoNoOTCPERRIGO R AND D CO1d715beae5342df29bb4cb93d980c89972c2e2f7a0c3de4b1303d821f9d30c24
432A212866001ESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALESOMEPRAZOLE MAGNESIUMSUN PHARMEQ 20MG BASE[]2020-05-04May 4, 2020NoNoNoOTCSUN PHARMACEUTICAL INDUSTRIES LTDea4b9916ff580a761d61e47cac57d3b519c59d69aabf0a264c49ef29612bb96d
433N202342001ESOMEPRAZOLE STRONTIUMCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALESOMEPRAZOLE STRONTIUMBELCHER24.65MG[]2013-08-06Aug 6, 2013NoYesNoDISCNBELCHER PHARMATECH LLC3c98b5e1a84d46187395469ab369d17e3f92b70eb72710428b5c7067453dc69b
434N202342002ESOMEPRAZOLE STRONTIUMCAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALESOMEPRAZOLE STRONTIUMBELCHER49.3MG[]2013-08-06Aug 6, 2013NoYesNoDISCNBELCHER PHARMATECH LLC490adf11a88292ab299beb1d3c12f79de2b453c5ca4785f031f9b8501debbb01
435A200920001CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDACTAVIS ELIZABETHEQ 45MG FENOFIBRIC ACIDAB["AB"]2015-10-07Oct 7, 2015NoNoNoRXACTAVIS ELIZABETH LLCbf1d050df97995726854a9e100d0737e8aa75add9471f2bccf3518c8f623db84
436A200920002CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDACTAVIS ELIZABETHEQ 135MG FENOFIBRIC ACIDAB["AB"]2015-10-07Oct 7, 2015NoNoNoRXACTAVIS ELIZABETH LLC559fd04d41c78636d0945731a25d1bdfa3439633f0ae0780fdfd100a73ec24d2
437A208705001CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDALEMBIC PHARMS LTDEQ 45MG FENOFIBRIC ACIDAB["AB"]2017-05-12May 12, 2017NoNoNoRXALEMBIC PHARMACEUTICALS LTDdc67bd297ee38dbbffe23e22f87a564fc89be0309f9869b3b7162be9e93ba5e4
438A208705002CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDALEMBIC PHARMS LTDEQ 135MG FENOFIBRIC ACIDAB["AB"]2017-05-12May 12, 2017NoNoNoRXALEMBIC PHARMACEUTICALS LTD5ffa147b76390321ca3719c5a59b9bdb310b560269497b92cc068ec277f10447
439A201573002CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDANCHEN PHARMSEQ 45MG FENOFIBRIC ACIDAB["AB"]2013-07-18Jul 18, 2013NoNoNoRXANCHEN PHARMACEUTICALS INC8019fb9dfaff64b16b305ae60017dd99a954dd7ae2dc6226f6ab3a7425d0561f
440A201573001CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDANCHEN PHARMSEQ 135MG FENOFIBRIC ACIDAB["AB"]2013-07-18Jul 18, 2013NoNoNoRXANCHEN PHARMACEUTICALS INC5243e249e6f2e7fc4c83cdde6bb394226ace80aecc3778589d162427b6923961
441A212598001CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDAUROBINDO PHARMA LTDEQ 45MG FENOFIBRIC ACIDAB["AB"]2019-07-25Jul 25, 2019NoNoNoRXAUROBINDO PHARMA LTDb74dd105e5f256f78dadb73d415d188ad84a1917eb93d60ae65ceaa97c20416f
442A212598002CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDAUROBINDO PHARMA LTDEQ 135MG FENOFIBRIC ACIDAB["AB"]2019-07-25Jul 25, 2019NoNoNoRXAUROBINDO PHARMA LTD5bf5c7d48a25f7d1878d8239f2bf399a03b3211398f7c7852ca25f1e68687532
443A211626001CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDGRAVITI PHARMSEQ 45MG FENOFIBRIC ACIDAB["AB"]2019-07-18Jul 18, 2019NoNoNoRXGRAVITI PHARMACEUTICALS PRIVATE LTD476164baf0e97ee6a4fa404e253d73424a35c0e960881c05b6e634c961e3e3f7
444A211626002CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDGRAVITI PHARMSEQ 135MG FENOFIBRIC ACIDAB["AB"]2019-07-18Jul 18, 2019NoNoNoRXGRAVITI PHARMACEUTICALS PRIVATE LTD6bc60566fd21d2887868b43df27ca7524439319357bf41cc6d857b8d8c7d9a36
445A200264001CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDIMPAX LABS INCEQ 45MG FENOFIBRIC ACIDAB["AB"]2016-09-07Sep 7, 2016NoNoNoRXIMPAX LABORATORIES INC2c41610b3e837f38e03f28f0808d05ed3fd3b3b9f71548f2ac7363a0759515d1
446A200264002CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDIMPAX LABS INCEQ 135MG FENOFIBRIC ACIDAB["AB"]2016-09-07Sep 7, 2016NoNoNoRXIMPAX LABORATORIES INC822b97b8a0634cf68807ddcbe8f9cab8fc3b25764de62b45643696bbc11fa1b1
447A200750001CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDLUPIN LTDEQ 45MG FENOFIBRIC ACIDAB["AB"]2013-12-04Dec 4, 2013NoNoNoRXLUPIN LTDd3d33ff3b22bc0fbfedf2bde52cfae534af6881e072eab94a79f469e9b01d0ee
448A200750002CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDLUPIN LTDEQ 135MG FENOFIBRIC ACIDAB["AB"]2013-12-04Dec 4, 2013NoNoNoRXLUPIN LTD83732e97e2d57b5db7638a46789f352c7de6ca7590706c14ce4eb4f83baaaff7
449A213450001CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDMICRO LABSEQ 45MG FENOFIBRIC ACIDAB["AB"]2020-06-16Jun 16, 2020NoNoNoRXMICRO LABS LTD8fe53d6a31850f84cec0d5617c0833ed92ebbf25dee9f0c751ef8c604b5a3e84
450A213450002CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDMICRO LABSEQ 135MG FENOFIBRIC ACIDAB["AB"]2020-06-16Jun 16, 2020NoNoNoRXMICRO LABS LTD412c684e7656280d6177d885e62ca0cfe8ecf8a94a66a9cf758c664174e3052c
451A200913001CHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALCAPSULE, DELAYED RELEASEORALFENOFIBRIC ACIDMYLAN PHARMS INCEQ 45MG FENOFIBRIC ACID[]2013-03-25Mar 25, 2013NoNoNoDISCNMYLAN PHARMACEUTICALS INC1551917e93dfbb3a80b3ea9d7e7f3d02166e0c4226b598741b1b9e4e656728fe