← Snapshot 21

Orange Book snapshot 21: Products

Products page 20 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
952N020616003MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKADIANALLERGAN100MGAB["AB"]1996-07-03Jul 3, 1996NoYesYesRXALLERGAN SALES LLCeaf12c3ff079a6fc647c7de67961f3fcd97d84991db1174af4a75d8ad74a440f
953N020616011MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKADIANALLERGAN130MG[]2012-07-09Jul 9, 2012NoYesNoRXALLERGAN SALES LLC14e64f2e075789c3f34cda52d7c1187d4394d2a3fbf934b8a3045d8928a19afe
954N020616012MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKADIANALLERGAN150MG[]2012-07-09Jul 9, 2012NoYesNoRXALLERGAN SALES LLC03fcaae68250c6fcebcc87ae3fda4c5e141b0a0f8b9aa0cdc437dd8695cbd7c6
955N020616007MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKADIANALLERGAN200MG[]2007-02-27Feb 27, 2007NoYesYesRXALLERGAN SALES LLC31c067c07de5b306945b41641858f66bf87f8b8d03822f0c1f7b4da67b6ccc35
956N210428001METOPROLOL SUCCINATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKAPSPARGO SPRINKLESPILEQ 25MG TARTRATE[]2018-01-26Jan 26, 2018NoYesNoRXSUN PHARMA INDUSTRIES LTD59f5d2670ebc3b8f99f119f7196886c7ffa4f05faf95485d630060e19343ef41
957N210428002METOPROLOL SUCCINATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKAPSPARGO SPRINKLESPILEQ 50MG TARTRATE[]2018-01-26Jan 26, 2018NoYesNoRXSUN PHARMA INDUSTRIES LTDcc3a6f647a48f8a19d4ee1771175a9159dac037ac863272612f1221f0f3f0ed7
958N210428003METOPROLOL SUCCINATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKAPSPARGO SPRINKLESPILEQ 100MG TARTRATE[]2018-01-26Jan 26, 2018NoYesNoRXSUN PHARMA INDUSTRIES LTDf387fef582245134f22ea7e67697d4a9e524d70505ed4e5207ba11fdd652d6e2
959N210428004METOPROLOL SUCCINATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKAPSPARGO SPRINKLESPILEQ 200MG TARTRATE[]2018-01-26Jan 26, 2018NoYesYesRXSUN PHARMA INDUSTRIES LTD11c64514915e6626d9a55bf8d687cbeb78fec4ab55d32ecc24dca702192f2ab3
960A075270002KETOPROFENCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKETOPROFENACTAVIS LABS FL INC100MG[]1999-03-24Mar 24, 1999NoNoNoDISCNACTAVIS LABORATORIES FL INC51d690cea74cc97c14964572dfc232ed91eed02b4f2065e876db8bf20aace01f
961A075270003KETOPROFENCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKETOPROFENACTAVIS LABS FL INC150MG[]1999-03-24Mar 24, 1999NoNoNoDISCNACTAVIS LABORATORIES FL INC1614529e07b6562acc8cf430702dcd7f2dd13162f8e71c1c03e5c87e060d74b5
962A075270001KETOPROFENCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKETOPROFENACTAVIS LABS FL INC200MG[]1999-03-24Mar 24, 1999NoNoNoDISCNACTAVIS LABORATORIES FL INC93da12a961b14cf4cdc3f2da990f4b9f4372c456f773b5257f84133ff0a33e64
963A074879001KETOPROFENCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKETOPROFENALKERMES GAINESVILLE200MG[]1997-12-10Dec 10, 1997NoNoNoDISCNALKERMES GAINESVILLE LLCb77d4854186ba2a1e4dca1e70678699c36190805b72f5ee13a3aac05be79fbb3
964A075679003KETOPROFENCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKETOPROFENMYLAN100MG[]2002-02-20Feb 20, 2002NoNoNoDISCNMYLAN PHARMACEUTICALS INC6f85434334601ff60ee914e2a2780a7c03c759faa99772a3cb41f44fb17848bb
965A075679002KETOPROFENCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKETOPROFENMYLAN150MG[]2002-02-20Feb 20, 2002NoNoNoDISCNMYLAN PHARMACEUTICALS INC61a9212ae462956d50ad5cfdf02b636b2fe162b5ddfd9585549701bc908ba82c
966A075679001KETOPROFENCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKETOPROFENMYLAN200MG[]2002-02-20Feb 20, 2002NoNoYesRXMYLAN PHARMACEUTICALS INC2ed049515f6d0f35dba4576c9a6f4ae76373080387bc23db7907bbbf31e04304
967A203106001POTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKLOR-CONUPSHER SMITH LABS8MEQAB["AB"]2015-07-10Jul 10, 2015NoNoNoRXUPSHER SMITH LABORATORIES LLC846171f3123ee89a93d231f1ef8a01f6ed5580732521e494a5e64a3ae5cdebe1
968A203106002POTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALKLOR-CONUPSHER SMITH LABS10MEQAB["AB"]2015-07-10Jul 10, 2015NoNoNoRXUPSHER SMITH LABORATORIES LLC81134a61cc2b024da8c54b8cef2e9076d22c5d6ef62da0697c189a2cccd793c5
969A210790001LEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALLEVOMILNACIPRAN HYDROCHLORIDEAMNEAL PHARMS COEQ 20MG BASE[]2019-02-04Feb 4, 2019NoNoNoDISCNAMNEAL PHARMACEUTICALS CO GMBH7f05072b9a1565fb232cdcd0fecb6d4336b4a96cb8de547524157148ad69926b
970A210790002LEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALLEVOMILNACIPRAN HYDROCHLORIDEAMNEAL PHARMS COEQ 40MG BASE[]2019-02-04Feb 4, 2019NoNoNoDISCNAMNEAL PHARMACEUTICALS CO GMBH4ddc81954f45fdeb7594e3f316e97cce1dc7c1c829be13c774edf546fa42b1af
971A210790003LEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALLEVOMILNACIPRAN HYDROCHLORIDEAMNEAL PHARMS COEQ 80MG BASE[]2019-02-04Feb 4, 2019NoNoNoDISCNAMNEAL PHARMACEUTICALS CO GMBHa49b420a068e82885e9c46ec89730901c4113a78f4d53744d6e8a29a3841ad2f
972A210790004LEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALLEVOMILNACIPRAN HYDROCHLORIDEAMNEAL PHARMS COEQ 120MG BASE[]2019-02-04Feb 4, 2019NoNoNoDISCNAMNEAL PHARMACEUTICALS CO GMBH34695bc084d932366bc2dad01449aa593be50b35d92fa6d867f0b9bfe7f6f547
973A210732001LEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALLEVOMILNACIPRAN HYDROCHLORIDEHIKMAEQ 20MG BASEAB["AB"]2020-11-05Nov 5, 2020NoNoNoRXHIKMA PHARMACEUTICALS USA INC53ac233684504466d4f228b8247c11591c9dd4c7fc38c36b13307af2eda60f4b
974A210732002LEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALLEVOMILNACIPRAN HYDROCHLORIDEHIKMAEQ 40MG BASEAB["AB"]2020-11-05Nov 5, 2020NoNoNoRXHIKMA PHARMACEUTICALS USA INC61c0d4575f58196ac53487b34764378cfcf5177ed9729470057af1a2ea9c82b0
975A210732003LEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALLEVOMILNACIPRAN HYDROCHLORIDEHIKMAEQ 80MG BASEAB["AB"]2020-11-05Nov 5, 2020NoNoNoRXHIKMA PHARMACEUTICALS USA INC3c97507c33ff649d1f645d42a71d3c506960721bccefe2b8f7d3989da79c2cdd
976A210732004LEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALLEVOMILNACIPRAN HYDROCHLORIDEHIKMAEQ 120MG BASEAB["AB"]2020-11-05Nov 5, 2020NoNoNoRXHIKMA PHARMACEUTICALS USA INCfdcc85e9041413e53422decaa6f85a804408d87c2a8645825a63c791ecbae967
977N017813001CHLORDIAZEPOXIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALLIBRELEASEVALEANT PHARM INTL30MG[]1983-09-12Sep 12, 1983NoNoNoDISCNVALEANT PHARMACEUTICALS INTERNATIONAL65c5e13874edb1cf1420bd71943edcf7029b8102682a188bdd2839f28b0dece3
978N022033001FLUVOXAMINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALLUVOX CRJAZZ PHARMS100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]2008-02-28Feb 28, 2008NoYesNoDISCNJAZZ PHARMACEUTICALS INCf3938294fdf2867d120f578c49f400d06c66c8e23beb1aa9553538a4069723f7
979N022033002FLUVOXAMINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALLUVOX CRJAZZ PHARMS150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]2008-02-28Feb 28, 2008NoYesNoDISCNJAZZ PHARMACEUTICALS INC909e09de7ee49d5ae2b8bc8f238ae95064737a0666339a56bdafafcc488c4046
980A087487001PHENDIMETRAZINE TARTRATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMELFIAT-105NUMARK105MG[]1982-10-13Oct 13, 1982NoNoNoDISCNNUMARK LABORATORIES INCdc8aacf66cf85e61b3bd6c45d76941597a6be3145df95b2ea7fee017e66cc612
981A205825001MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEAMNEAL PHARMS7MGAB["AB"]2016-10-12Oct 12, 2016NoNoNoRXAMNEAL PHARMACEUTICALS OF NEW YORK LLCd50704c5e9ba3fb607b1ed2e65c88fa85034fdbba2c949ff7eb9c071b5c08195
982A205825002MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEAMNEAL PHARMS14MGAB["AB"]2016-10-12Oct 12, 2016NoNoNoRXAMNEAL PHARMACEUTICALS OF NEW YORK LLCb2113daa5d015909daa6f00c06f017aa3fe89d9da8b4500a01a4d4f9204454d6
983A205825003MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEAMNEAL PHARMS21MGAB["AB"]2016-10-12Oct 12, 2016NoNoNoRXAMNEAL PHARMACEUTICALS OF NEW YORK LLCc6114720d0d85db724971bd3f2d49d0cba0645ac57af25f788386b5330f903ee
984A205825004MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEAMNEAL PHARMS28MGAB["AB"]2016-10-12Oct 12, 2016NoNoNoRXAMNEAL PHARMACEUTICALS OF NEW YORK LLC8b6a374e002a4737f8e10121da5972cdc10f8b6b12f7cc395d6ef99f15d6e87f
985A205784001MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEANCHEN PHARMS7MGAB["AB"]2017-06-09Jun 9, 2017NoNoNoRXANCHEN PHARMACEUTICALS INC772917342bad517926160433235b48a267ff3da579b71504f3b29fbf3b33aeec
986A205784002MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEANCHEN PHARMS14MGAB["AB"]2017-06-09Jun 9, 2017NoNoNoRXANCHEN PHARMACEUTICALS INCde5b197239d06e8d45e397cad1ac81210977baac4e65257c5cb815af917976d8
987A205784003MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEANCHEN PHARMS21MGAB["AB"]2017-06-09Jun 9, 2017NoNoNoRXANCHEN PHARMACEUTICALS INC20988c7ffb40f6cbc38f3b2031b2ec3d41cd2e77adbb3bc1a7dc3c4eccf5aa2b
988A205784004MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEANCHEN PHARMS28MGAB["AB"]2017-06-09Jun 9, 2017NoNoNoRXANCHEN PHARMACEUTICALS INCaf331cb4bb1f4fd415149e7b5ce26ec45777a7d15b034c04802e033ec7a6b243
989A205365001MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEANI PHARMS INC7MGAB["AB"]2020-02-28Feb 28, 2020NoNoNoRXANI PHARMACEUTICALS INCfa4d1fa714e90213afec6b64eacaa2f257d9a6d73a05425bf6692f62f9be8b00
990A205365002MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEANI PHARMS INC14MGAB["AB"]2020-02-28Feb 28, 2020NoNoNoRXANI PHARMACEUTICALS INC7796adb9eae1974af140c8ba1376613ee102b33307c991a61f04e8e121f558e0
991A205365003MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEANI PHARMS INC21MGAB["AB"]2020-02-28Feb 28, 2020NoNoNoRXANI PHARMACEUTICALS INCaf4d2d05eaef4495bac34526df5a4771c7c03819a1701640e0c8f569209635ca
992A205365004MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEANI PHARMS INC28MGAB["AB"]2020-02-28Feb 28, 2020NoNoNoRXANI PHARMACEUTICALS INCd5caca57b7076a17a27aadbd27842374fb1984acbd91fa27b9b08fd0ba6232c8
993A206135001MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEAPOTEX7MGAB["AB"]2016-11-22Nov 22, 2016NoNoNoRXAPOTEX INC5850c03493b7b002bba1de31101561755b22d5574b9409977079c3e4a3e08f38
994A206135002MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEAPOTEX14MGAB["AB"]2016-11-22Nov 22, 2016NoNoNoRXAPOTEX INCbc117ab80aa059f1f35e80bf1ca393638b2f56de8a7a7aee91a6fd5f27c6b300
995A206135003MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEAPOTEX21MGAB["AB"]2016-11-22Nov 22, 2016NoNoNoRXAPOTEX INC90f32258077f825a92ecdeb1370169111ad3b2f61c955f62a86a2fa9b1a10525
996A206135004MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEAPOTEX28MGAB["AB"]2016-11-22Nov 22, 2016NoNoNoRXAPOTEX INC66727bbf7f977bfef1765298ec72b65d61d8392a037571d5c21d97547d5bd41e
997A206028001MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDELUPIN LTD7MGAB["AB"]2016-09-28Sep 28, 2016NoNoNoRXLUPIN LTDa20e74f470660a21867df8ef08ee8f480736623da3c10c66f7c33cef823de8bc
998A206028002MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDELUPIN LTD14MGAB["AB"]2016-09-28Sep 28, 2016NoNoNoRXLUPIN LTDcb5a4800a813f728c53d5c5d4d64f631fc282e1de711515e2c53c06d930f4d57
999A206028003MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDELUPIN LTD21MGAB["AB"]2016-09-28Sep 28, 2016NoNoNoRXLUPIN LTDffb953f36d90dd39f02c978bd671a40f7787c687252315881ecab109a362502e
1000A206028004MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDELUPIN LTD28MGAB["AB"]2016-09-28Sep 28, 2016NoNoNoRXLUPIN LTDc10aaf35442746ea34f75f8e110a8aa187ac726a2cd0ba81f72f65be58400c48
1001A206032001MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMEMANTINE HYDROCHLORIDEMYLAN7MGAB["AB"]2016-09-28Sep 28, 2016NoNoNoRXMYLAN PHARMACEUTICALS INC5cdd31f27573d2e4dcecbcdf630d9edcdc868808c5cc71cd1f43c5e6e3fedec5