← Snapshot 21

Orange Book snapshot 21: Products

Products page 18 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
852A086826002THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALELIXOPHYLLIN SRFOREST LABS250MG[]1985-01-29Jan 29, 1985NoNoNoDISCNFOREST LABORATORIES INC8f5ec7d0c18a6e4534a5532e65b7c3a6baf332dae574954f8848183949a1b404
853N022321001MORPHINE SULFATE; NALTREXONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALEMBEDAALPHARMA PHARMS20MG;0.8MG[]2009-08-13Aug 13, 2009NoYesNoDISCNALPHARMA PHARMACEUTICALS LLC00295d036a5ccf3ce396b5314a2bde339f08e31472c10b8b7fe388758b7f135e
854N022321002MORPHINE SULFATE; NALTREXONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALEMBEDAALPHARMA PHARMS30MG;1.2MG[]2009-08-13Aug 13, 2009NoYesNoDISCNALPHARMA PHARMACEUTICALS LLC7b7dca7164101362c0420d55d87570453b2ed7ffc13bce8c98bbbbce2fe4597d
855N022321003MORPHINE SULFATE; NALTREXONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALEMBEDAALPHARMA PHARMS50MG;2MG[]2009-08-13Aug 13, 2009NoYesNoDISCNALPHARMA PHARMACEUTICALS LLC8a805bf74549028892280d791c478328ab98f665edbf71c77fed1e7377843ad2
856N022321004MORPHINE SULFATE; NALTREXONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALEMBEDAALPHARMA PHARMS60MG;2.4MG[]2009-08-13Aug 13, 2009NoYesNoDISCNALPHARMA PHARMACEUTICALS LLC9cec45e1ceaa0064f1ed9d5e1aa6a6dbf55ccdde6fbcdcac7ae7af99fdc81a66
857N022321005MORPHINE SULFATE; NALTREXONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALEMBEDAALPHARMA PHARMS80MG;3.2MG[]2009-08-13Aug 13, 2009NoYesNoDISCNALPHARMA PHARMACEUTICALS LLCa09dfff46949f0976edcf6a82922698af039840b6fba8600f4d93dbb9e2a6eb2
858N022321006MORPHINE SULFATE; NALTREXONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALEMBEDAALPHARMA PHARMS100MG;4MG[]2009-08-13Aug 13, 2009NoYesNoDISCNALPHARMA PHARMACEUTICALS LLCafcf9aa2cafec2c072466a53777ab752479a641f204814c3c8ddbbb2f80736dc
859N021710001CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALEQUETROVALIDUS PHARMS100MG[]2004-12-10Dec 10, 2004NoYesNoRXVALIDUS PHARMACEUTICALS LLCa343d6bb9a4d8a11325626ddd711c22cfa76eb3fe19a2cdd84d77965d50eeb52
860N021710002CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALEQUETROVALIDUS PHARMS200MG[]2004-12-10Dec 10, 2004NoYesNoRXVALIDUS PHARMACEUTICALS LLC9f012426b55b6f117ea0de3cd5a472e2dcf41ce7f7d3fd3785bfc5eff926d9ab
861N021710003CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALEQUETROVALIDUS PHARMS300MG[]2004-12-10Dec 10, 2004NoYesYesRXVALIDUS PHARMACEUTICALS LLC7fdecc1ccc0b9119d0fd11aad919bd1814ba1e7a5ea02522a327de8d9a83e796
862N204168001LEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFETZIMAALLERGANEQ 20MG BASEAB["AB"]2013-07-25Jul 25, 2013NoYesNoRXALLERGAN SALES LLCbd03f3400a2f49a17b8dee181569ebe5f6f9416be13d8e66af6d6fab5287a24d
863N204168002LEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFETZIMAALLERGANEQ 40MG BASEAB["AB"]2013-07-25Jul 25, 2013NoYesNoRXALLERGAN SALES LLC2aa6acc7669e0011b24de014f7e75b2d27a34e6986af354890e70e6bf3a1b13f
864N204168003LEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFETZIMAALLERGANEQ 80MG BASEAB["AB"]2013-07-25Jul 25, 2013NoYesNoRXALLERGAN SALES LLCd2a6e64be8c47f1e86ab7f71226a2bdc1add7df1ed5c3dd7f2615fdd78495ff7
865N204168004LEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFETZIMAALLERGANEQ 120MG BASEAB["AB"]2013-07-25Jul 25, 2013NoYesYesRXALLERGAN SALES LLC81ded6712dd03ae8ee7ad14ff5a3d018603a53c70ef290120b1aad7bc6fff60f
866A091482001FLUVOXAMINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFLUVOXAMINE MALEATEACTAVIS ELIZABETH100MGAB["AB"]2013-04-23Apr 23, 2013NoNoNoRXACTAVIS ELIZABETH LLC2430dba8d390bfd74a7f15b21d11efbd7dafb7a1ba82bf96819b4b14368fbeff
867A091482002FLUVOXAMINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFLUVOXAMINE MALEATEACTAVIS ELIZABETH150MGAB["AB"]2013-11-18Nov 18, 2013NoNoYesRXACTAVIS ELIZABETH LLCcdae62d2d9809ba052259553d5a2f55e660c9ce1a35c0297223f5f96a41c7659
868A091476001FLUVOXAMINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFLUVOXAMINE MALEATEANCHEN PHARMS100MGAB["AB"]2013-03-13Mar 13, 2013NoNoNoRXANCHEN PHARMACEUTICALS INC5037b6c72b79fd5f2aabd8e7e5cb83dbe4c5e2a859490b09432828969e3851ed
869A091476002FLUVOXAMINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFLUVOXAMINE MALEATEANCHEN PHARMS150MGAB["AB"]2013-03-13Mar 13, 2013NoNoNoRXANCHEN PHARMACEUTICALS INC3b57d0cc29f48b38e444c7620cf3f48a08ddbeab46b36307b3c6cd7e5a13433c
870A212182002FLUVOXAMINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFLUVOXAMINE MALEATEBIONPHARMA INC100MG[]2020-09-16Sep 16, 2020NoNoNoDISCNBIONPHARMA INC0b9683ca841720093115f4914b96e6f7e440d2e4f8f69e25ad1120514d1dd800
871A212182001FLUVOXAMINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFLUVOXAMINE MALEATEBIONPHARMA INC150MGAB["AB"]2020-05-11May 11, 2020NoNoNoRXBIONPHARMA INCa9f87dde4fb7bd530bf647307fadf2de1ccaf3af9c322ef81edf44a3749333b3
872A203240001FLUVOXAMINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFLUVOXAMINE MALEATETORRENT100MG[]2014-10-31Oct 31, 2014NoNoNoDISCNTORRENT PHARMACEUTICALS LTD0d01efc728ab27a6dd90cd505d6b7801752b2afb5aa9c381ec7f94ac26126806
873A203240002FLUVOXAMINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFLUVOXAMINE MALEATETORRENT150MG[]2014-10-31Oct 31, 2014NoNoNoDISCNTORRENT PHARMACEUTICALS LTD2a1e07c4a6935119c2be24720ffcb080d566c7df61ac02006ca9822c83603f6d
874N021802001DEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFOCALIN XRNOVARTIS5MGAB["AB"]2005-05-26May 26, 2005NoYesNoRXNOVARTIS PHARMACEUTICALS CORPa27808d76d0f4225134cd96bd768f3f30cd3f2348249502b4c10f305da85dc95
875N021802002DEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFOCALIN XRNOVARTIS10MGAB["AB"]2005-05-26May 26, 2005NoYesNoRXNOVARTIS PHARMACEUTICALS CORP443dbec9c0e2b12494d94a24607599a40acad62cd83ed8f15aac45d6e0f46ef1
876N021802004DEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFOCALIN XRNOVARTIS15MGAB["AB"]2006-08-01Aug 1, 2006NoYesNoRXNOVARTIS PHARMACEUTICALS CORP138243e8797edab7d358c820d394e1cde68ff6c17e0cb7bb2865e15b2e590136
877N021802003DEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFOCALIN XRNOVARTIS20MGAB["AB"]2005-05-26May 26, 2005NoYesNoRXNOVARTIS PHARMACEUTICALS CORP32003efa165a80ed1b8bc600ad5f34a28d39ac2c3543e0d85268a2454317d5f4
878N021802008DEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFOCALIN XRNOVARTIS25MGAB["AB"]2011-04-21Apr 21, 2011NoYesNoRXNOVARTIS PHARMACEUTICALS CORP2c378b60176dcf9697d871a84f364dce4177a66d3d7341a4c3d3b695add0f884
879N021802005DEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFOCALIN XRNOVARTIS30MGAB["AB"]2009-10-23Oct 23, 2009NoYesNoRXNOVARTIS PHARMACEUTICALS CORP94069872c56cc8d1f6f5ab2376dc8bdd2c53ca0fa0547d41e5454c10c7a7610c
880N021802007DEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFOCALIN XRNOVARTIS35MGAB["AB"]2011-04-21Apr 21, 2011NoYesNoRXNOVARTIS PHARMACEUTICALS CORP5e095830c14ea110a6e931dab5af99ba2c67177199a03ba4e5e67d729f921d28
881N021802006DEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALFOCALIN XRNOVARTIS40MGAB["AB"]2010-08-11Aug 11, 2010NoYesYesRXNOVARTIS PHARMACEUTICALS CORP58b0342371d452ff72e0311086ac85f628793a14ff0cb1c3be77ef8257bc6d32
882A204895001GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDEAUROBINDO PHARMA LTDEQ 8MG BASEAB["AB"]2016-08-05Aug 5, 2016NoNoNoRXAUROBINDO PHARMA LTDbb356355e8cf1d35a88072bd53d8bf5217e92c6f8c195ae8a2b28f5d99e6cefa
883A204895002GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDEAUROBINDO PHARMA LTDEQ 16MG BASEAB["AB"]2016-08-05Aug 5, 2016NoNoNoRXAUROBINDO PHARMA LTD4d152f8386f811d50d3548b966eebacaaa49f39c7ff7d8d65257dd31dda15320
884A204895003GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDEAUROBINDO PHARMA LTDEQ 24MG BASEAB["AB"]2016-08-05Aug 5, 2016NoNoNoRXAUROBINDO PHARMA LTD4f0d464a0da73775ec7ed53a89f64b53c4506aa2d5a858dbbe887410b0ac1b3c
885A078189001GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDEBARREQ 8MG BASEAB["AB"]2008-09-15Sep 15, 2008NoNoNoRXBARR LABORATORIES INCf85dbe95e2239afaad0784848a2c0abfbef41ab731c34a33032c22da764c1ae4
886A078189002GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDEBARREQ 16MG BASEAB["AB"]2008-09-15Sep 15, 2008NoNoNoRXBARR LABORATORIES INCce6772f8a36401da5f87d51b835d007464deb77b340b3a61c6b45ee15fc970d2
887A078189003GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDEBARREQ 24MG BASEAB["AB"]2008-09-15Sep 15, 2008NoNoNoRXBARR LABORATORIES INC6504bf1ddfcff6f8711e1ceca4e64e87ecd29d26e8be03138b95e31d3a1b9b29
888A078484001GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDEIMPAX LABSEQ 8MG BASE[]2009-05-27May 27, 2009NoNoNoDISCNIMPAX LABORATORIES INC04251e7062e039beb17bd392c79b29c62b527f59ed80a60fd77ddc6768d8d95f
889A078484002GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDEIMPAX LABSEQ 16MG BASE[]2009-05-27May 27, 2009NoNoNoDISCNIMPAX LABORATORIES INCf263f417e4781fa6d196be4625f7089afad89ba01dc94c6404fcbfe52cb62b47
890A078484003GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDEIMPAX LABSEQ 24MG BASE[]2009-05-27May 27, 2009NoNoNoDISCNIMPAX LABORATORIES INC4fd69a8873cbba9215af7b1c5a5626e63e36f51efa15551bd29838cc39289f3d
891A090900001GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDEMYLANEQ 8MG BASE[]2011-01-24Jan 24, 2011NoNoNoDISCNMYLAN PHARMACEUTICALS INC54310e363cfc1faf60cdb5bde08e7792135aa1ba9a297571b9f024c1a5927c0c
892A090900002GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDEMYLANEQ 16MG BASE[]2011-01-24Jan 24, 2011NoNoNoDISCNMYLAN PHARMACEUTICALS INCda911deff57a1cef485a97a062086eab35cbefe5e107ac232b97b8d4f47edef6
893A090900003GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDEMYLANEQ 24MG BASE[]2011-01-24Jan 24, 2011NoNoNoDISCNMYLAN PHARMACEUTICALS INC1906320e529c0b5b66e1663fc34e7074f4152ef192c7a2c9519d5e8a7fb0b710
894A090178001GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDESUN PHARMEQ 8MG BASEAB["AB"]2011-02-02Feb 2, 2011NoNoNoRXSUN PHARMACEUTICAL INDUSTRIES LTD7973a306c17d3da4cecc5711c4afcceb68683f7e89cd79464a1917d9d7fb032f
895A090178002GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDESUN PHARMEQ 16MG BASEAB["AB"]2011-02-02Feb 2, 2011NoNoNoRXSUN PHARMACEUTICAL INDUSTRIES LTD93c4b47af02f471d2c25da41432ed02a7ee5a2f67bc6c82e3fa146d4fb67baa2
896A090178003GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDESUN PHARMEQ 24MG BASEAB["AB"]2011-02-02Feb 2, 2011NoNoNoRXSUN PHARMACEUTICAL INDUSTRIES LTDda947f62908aeba157013c90682532f27cb95bc2d7861a23e3b296bfb37f8ebd
897A079028001GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDEWATSON LABSEQ 8MG BASEAB["AB"]2008-12-15Dec 15, 2008NoNoNoRXWATSON LABORATORIES INC8463f7b5dfd755a9770cd807c7927c0f7bb831866a266bac6f35d0ceec314628
898A079028002GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDEWATSON LABSEQ 16MG BASEAB["AB"]2008-12-15Dec 15, 2008NoNoNoRXWATSON LABORATORIES INCe38d82f4399510b5e05cf7110090817e867494251722d4c88da1cdd1598e301f
899A079028003GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGALANTAMINE HYDROBROMIDEWATSON LABSEQ 24MG BASEAB["AB"]2008-12-15Dec 15, 2008NoNoNoRXWATSON LABORATORIES INC1a90e2945153e9a78fce8d6758e61baca66b4e78b2a40decf242fadb1b7566f5
900N208944001AMANTADINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGOCOVRIADAMAS PHARMAEQ 68.5MG BASE[]2017-08-24Aug 24, 2017NoYesNoRXADAMAS PHARMA LLC58758e010debcaab0fab6a1731da81037a20bc1304ea791c881abd09b1b6fb69
901N208944002AMANTADINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALGOCOVRIADAMAS PHARMAEQ 137MG BASE[]2017-08-24Aug 24, 2017NoYesYesRXADAMAS PHARMA LLC124fcec8e32b99717daa36c7e30dc02f8aed2b41d94501d25a0c52761e195e42