← Snapshot 21

Orange Book snapshot 21: Products

Products page 12 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
552N020062001DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARDIZEM CDBAUSCH120MGAB3["AB3"]1992-08-10Aug 10, 1992NoYesNoRXBAUSCH HEALTH US LLC85f2b8e0262c210f19c8cf08cffe6a8e65ba68f50c568cc38006a88fdb96af3d
553N020062002DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARDIZEM CDBAUSCH180MGAB3["AB3"]1991-12-27Dec 27, 1991NoYesNoRXBAUSCH HEALTH US LLC3a5818854432ade24a6c473a3557a3f88b0719f7e3d50f982ab901aa9d31341a
554N020062003DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARDIZEM CDBAUSCH240MGAB3["AB3"]1991-12-27Dec 27, 1991NoYesNoRXBAUSCH HEALTH US LLC17ea48213d756e0504e3630930614bd9d4b51181107ed1948fe8f553c41db5f0
555N020062004DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARDIZEM CDBAUSCH300MGAB3["AB3"]1991-12-27Dec 27, 1991NoYesNoRXBAUSCH HEALTH US LLCd4b4df0d35d72a456210dd263aa7baa94fd2b584517db1c0c98db655d6d9823b
556N020062005DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARDIZEM CDBAUSCH360MGAB3["AB3"]1999-08-24Aug 24, 1999NoYesYesRXBAUSCH HEALTH US LLCf76532690c1870f3c0dafab861f1e64d04f0df12d70bfaba7f76606dfd6b5e20
557N019471001DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARDIZEM SRBIOVAIL60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1989-01-23Jan 23, 1989NoYesNoDISCNBIOVAIL LABORATORIES INCf39938530e6788ffaf47322d24218d3b27e9e0eac65f48b6e14f013d2f539f9f
558N019471002DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARDIZEM SRBIOVAIL90MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1989-01-23Jan 23, 1989NoYesNoDISCNBIOVAIL LABORATORIES INC1c4f0573fed32f249ba731b9dc27ccf5762af0310e86b5d6f20a389f764d5d88
559N019471003DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARDIZEM SRBIOVAIL120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1989-01-23Jan 23, 1989NoYesNoDISCNBIOVAIL LABORATORIES INCd58df383dfdac2fe43f25db4d4700b908968280271b32503a6004d755ab47afa
560N019471004DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARDIZEM SRBIOVAIL180MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1989-01-23Jan 23, 1989NoYesNoDISCNBIOVAIL LABORATORIES INCfffa76956738fef6bc8949df820630ed4ac4df005763140c04e1b5198c86892e
561A074752002DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARTIA XTACTAVIS LABS FL INC120MGAB3["AB3"]1998-07-09Jul 9, 1998NoNoNoRXACTAVIS LABORATORIES FL INCb2b235405dc33710f1148f4bdf66aeea49ec166c25b622a6032ba079e8d3b1a4
562A074752001DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARTIA XTACTAVIS LABS FL INC180MGAB3["AB3"]1998-07-09Jul 9, 1998NoNoNoRXACTAVIS LABORATORIES FL INC958fbe4b938092a265ac9c08fb46ff8cf71fe4d47fd21834b777b50eaaa97145
563A074752003DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARTIA XTACTAVIS LABS FL INC240MGAB3["AB3"]1998-07-09Jul 9, 1998NoNoNoRXACTAVIS LABORATORIES FL INC16c384dd33650cec6ff54b321240f7a215809d96e4985ce7bae48ab3bb52b00f
564A074752004DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARTIA XTACTAVIS LABS FL INC300MGAB3["AB3"]1998-07-09Jul 9, 1998NoNoNoRXACTAVIS LABORATORIES FL INC9a2fe33d1fbf67d092ca00225da2425fba738e3c2c5b8d36857d592b53471d41
565A204717001CARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARVEDILOL PHOSPHATEIMPAX LABS INC10MGAB["AB"]2018-05-07May 7, 2018NoNoNoRXIMPAX LABORATORIES INC796788225f7557e8a11516dfd48572624c078eb838dd41e63d302c047ca4419d
566A204717002CARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARVEDILOL PHOSPHATEIMPAX LABS INC20MGAB["AB"]2018-05-07May 7, 2018NoNoNoRXIMPAX LABORATORIES INCb3a280bbc5759d8a599aae48d8e0d6f7dba8ceabbf268cf50fb88800b14bd71b
567A204717003CARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARVEDILOL PHOSPHATEIMPAX LABS INC40MGAB["AB"]2018-05-07May 7, 2018NoNoNoRXIMPAX LABORATORIES INCf99d5db07fb6d90ae3a673c197c6a7018ee4d028c6c608b1332b018aa5a4d0b9
568A204717004CARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARVEDILOL PHOSPHATEIMPAX LABS INC80MGAB["AB"]2018-05-07May 7, 2018NoNoNoRXIMPAX LABORATORIES INCf4fcbe4aa9f0c4286d9ff0b092a82a59645829a1429631dfa7d7291a0cae8732
569A090132001CARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARVEDILOL PHOSPHATESUN PHARM INDUSTRIES10MGAB["AB"]2017-10-25Oct 25, 2017NoNoNoRXSUN PHARMACEUTICAL INDUSTRIES INCc5ba932087293c9efb512daa0fccc32135c92396a23550f89aff323baff18296
570A090132002CARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARVEDILOL PHOSPHATESUN PHARM INDUSTRIES20MGAB["AB"]2017-10-25Oct 25, 2017NoNoNoRXSUN PHARMACEUTICAL INDUSTRIES INCf86de8e043e80f668aaf646dcd52f0e0d4d89488c887d0eaacace20c826bd41c
571A090132003CARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARVEDILOL PHOSPHATESUN PHARM INDUSTRIES40MGAB["AB"]2017-10-25Oct 25, 2017NoNoNoRXSUN PHARMACEUTICAL INDUSTRIES INCb1c4e1d71f1f78ee6cffb0afb784eb50ee48b7b00f7ad9543c9a147fc7746894
572A090132004CARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARVEDILOL PHOSPHATESUN PHARM INDUSTRIES80MGAB["AB"]2017-10-25Oct 25, 2017NoNoNoRXSUN PHARMACEUTICAL INDUSTRIES INC5fc19e3969fb2cb436fd7d5b50684bf387c32f9267ef2aca4f2453c35f837216
573A070797001CHLORPHENIRAMINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCHLORPHENIRAMINE MALEATEAUROLIFE PHARMA LLC12MG[]1988-08-12Aug 12, 1988NoNoNoDISCNAUROLIFE PHARMA LLCfe3b2fcb7afb3b36e4f1e2299dc5f37aa2c9f0c1728a9d47667ab410f35b88f0
574N018935001CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCODIMAL-L.A. 12SCHWARZ PHARMA12MG;120MG[]1985-04-15Apr 15, 1985NoNoNoDISCNSCHWARZ PHARMA INC09d738421c70b1910253f6544719489216eecf2de2a48c07e690c8afdd8f4ef9
575N018793001CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCOLD CAPSULE IVGRAHAM DM12MG;75MG[]1985-04-25Apr 25, 1985NoNoNoDISCNDM GRAHAM LABORATORIES INC333f75c649f060f1a316822d8dac6ed01815e01ce7ce180a931b9c2e35978261
576N018794001CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCOLD CAPSULE VGRAHAM DM8MG;75MG[]1985-04-23Apr 23, 1985NoNoNoDISCNDM GRAHAM LABORATORIES INC28a1089cbd3e7636dd1c8006ae883ab16411fe68826879f9907139e0df7e9a8a
577N011000001PROCHLORPERAZINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCOMPAZINEGLAXOSMITHKLINEEQ 10MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNGLAXOSMITHKLINEd68b75f7304f2e54facf050b5f27d6858aa271eee41b51f2cbce64a9c8d7bc51
578N021019001PROCHLORPERAZINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCOMPAZINEGLAXOSMITHKLINEEQ 10MG BASE[]1999-10-06Oct 6, 1999NoNoNoDISCNGLAXOSMITHKLINE43c0222991d7bf0e9188a1c97cf17d800ba71a024b76808d4006c7ab5e6dead1
579N011000002PROCHLORPERAZINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCOMPAZINEGLAXOSMITHKLINEEQ 15MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNGLAXOSMITHKLINEf22d392d9537038ba128e4caf0d5126bddc1964bb921f2e56a822c462cb4781b
580N021019002PROCHLORPERAZINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCOMPAZINEGLAXOSMITHKLINEEQ 15MG BASE[]1999-10-06Oct 6, 1999NoNoNoDISCNGLAXOSMITHKLINE7426692ad7befb4fa39e54784af69be531995b133d0ddb403b6a9593c9633daf
581N011000003PROCHLORPERAZINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCOMPAZINEGLAXOSMITHKLINEEQ 30MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNGLAXOSMITHKLINEb38348108dcb0f33bb5287893bec9697b465da369b980371ffd4532ce2cdf148
582N011000004PROCHLORPERAZINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCOMPAZINEGLAXOSMITHKLINEEQ 75MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNGLAXOSMITHKLINE25288e9e14cf3b96cc83c779ef07add52b52bfeff1d46ef41482045da7bb45bc
583N022370001TRAMADOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCONZIPCIPHER PHARMS INC100MG[]2010-05-07May 7, 2010NoYesYesRXCIPHER PHARMACEUTICALS INCa63e8e19fd07ef5caf0fbcdfda4d2cc1bd57af66f0c3baa57d25c963973d85e3
584N022370004TRAMADOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCONZIPCIPHER PHARMS INC150MG[]2011-08-01Aug 1, 2011NoYesNoDISCNCIPHER PHARMACEUTICALS INCae223b5e1588b3022246c56e85379d02ec10adaa6977562388cf976cfe135a92
585N022370002TRAMADOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCONZIPCIPHER PHARMS INC200MG[]2010-05-07May 7, 2010NoYesNoRXCIPHER PHARMACEUTICALS INC059a27dff4c6d5efa10b05e952a6650b61fdb5a3bb5bd866148ef538f901d475
586N022370003TRAMADOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCONZIPCIPHER PHARMS INC300MG[]2010-05-07May 7, 2010NoYesNoRXCIPHER PHARMACEUTICALS INC4bfc9e810eaf76bd1cb1cd82c1e8c6ec57c8d3b48f5c21b0f7fa02112325a465
587N022012001CARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCOREG CRSMITHKLINE BEECHAM10MGAB["AB"]2006-10-20Oct 20, 2006NoYesNoRXSMITHKLINE BEECHAM (CORK) LTD IRELAND7e7fd89799456dc03c5791174bcb6085a3b1d0371ff3070e3b99ba068b52fac5
588N022012002CARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCOREG CRSMITHKLINE BEECHAM20MGAB["AB"]2006-10-20Oct 20, 2006NoYesNoRXSMITHKLINE BEECHAM (CORK) LTD IRELAND151e912cbcd0f5fae74324916b3a611f6dc8b1fd0f282dbf2f5cc6605617ddc7
589N022012003CARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCOREG CRSMITHKLINE BEECHAM40MGAB["AB"]2006-10-20Oct 20, 2006NoYesYesRXSMITHKLINE BEECHAM (CORK) LTD IRELAND637d9f02bb9b3ab69cd7bdcf25686e25fca69a050b6d97020e10e0ac3808c542
590N022012004CARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCOREG CRSMITHKLINE BEECHAM80MGAB["AB"]2006-10-20Oct 20, 2006NoYesNoRXSMITHKLINE BEECHAM (CORK) LTD IRELAND4f21fea9d6df21d14a3e459fb1a8589f7dc9d0d2ed6c9f4d015f25254e34fcad
591A206703001CYCLOBENZAPRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCYCLOBENZAPRINE HYDROCHLORIDEAPOTEX15MGAB["AB"]2018-07-24Jul 24, 2018NoNoNoRXAPOTEX INCf14e59c492181729e50e6f9a21d0a4514623c181b79e278e9601084ae70f5f95
592A206703002CYCLOBENZAPRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCYCLOBENZAPRINE HYDROCHLORIDEAPOTEX30MGAB["AB"]2018-07-24Jul 24, 2018NoNoNoRXAPOTEX INCbb5b9acc0d2fa1f12000cdad91b7fcd48372af41b443ac842954a417664a6ce2
593A091281001CYCLOBENZAPRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCYCLOBENZAPRINE HYDROCHLORIDETWI PHARMS INC15MGAB["AB"]2013-01-31Jan 31, 2013NoNoNoRXTWI PHARMACEUTICALS INCaed5e5c52bb210f8bb24f74cd532ba8e5b2e69ba33d2a42796227f67145c36d4
594A091281002CYCLOBENZAPRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCYCLOBENZAPRINE HYDROCHLORIDETWI PHARMS INC30MGAB["AB"]2013-01-31Jan 31, 2013NoNoNoRXTWI PHARMACEUTICALS INC9ea0a0bcae18b123f46fcdaef901cec9df9ce61b5c492f130daa3a75b67e43ac
595N021228001TOLTERODINE TARTRATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALDETROL LAUPJOHN2MGAB["AB"]2000-12-22Dec 22, 2000NoYesNoRXUPJOHN US 2 LLCc89afda92532419ad42c5f6e1905dc909adf272687093b2d0769735035c90374
596N021228002TOLTERODINE TARTRATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALDETROL LAUPJOHN4MGAB["AB"]2000-12-22Dec 22, 2000NoYesYesRXUPJOHN US 2 LLCdc64501298f5e69129a09a5a1789d955c9f3fb09e45b6d4528feba0a2c75f370
597N017078001DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALDEXEDRINEIMPAX LABS INC5MGAB["AB"]Approved Prior to Jan 1, 1982YesYesNoRXIMPAX LABORATORIES INC3cf1196ee14bff0d4f40923921849259fb0ed83a4139dfb5a59652bf513ce18d
598N017078002DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALDEXEDRINEIMPAX LABS INC10MGAB["AB"]Approved Prior to Jan 1, 1982YesYesNoRXIMPAX LABORATORIES INC2f3f5292d0c9fa3ef534a6ff412f7c4b80179cd1bbd7c27567fde867b8b638d0
599N017078003DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALDEXEDRINEIMPAX LABS INC15MGAB["AB"]Approved Prior to Jan 1, 1982YesYesYesRXIMPAX LABORATORIES INCba727ecbda41ec04b52fe0380d53163fb6c1f0450ac7c2a844676eaacf2e9a02
600A210279001DEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALDEXMETHYLPHENIDATE HYDROCHLORIDEADARE PHARMS INC5MGAB["AB"]2018-10-09Oct 9, 2018NoNoNoRXADARE PHARMACEUTICALS INC4c7c741bef84f6fc6163d2ce94ed353929a9d5eb22cc009d72cde09311f51ef6
601A210279002DEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALDEXMETHYLPHENIDATE HYDROCHLORIDEADARE PHARMS INC10MGAB["AB"]2018-10-09Oct 9, 2018NoNoNoRXADARE PHARMACEUTICALS INC55fca20b3d502f6d745ae6442c5c46448fa2911eb0bcb8da076cffff12c94fd8