← Snapshot 21

Orange Book snapshot 21: Products

Products page 64 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
3152N006012003FERROUS SULFATE; FOLIC ACIDCAPSULE;ORALCAPSULEORALFOLVRONLEDERLE182MG;0.33MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNLEDERLE LABORATORIES DIV AMERICAN CYANAMID CO80a7280b8d251242d0ff206703c17ef7387a1ed510e5eb89d7fe7f0b3f4d5d20
3153N020828001SAQUINAVIRCAPSULE;ORALCAPSULEORALFORTOVASEHOFFMANN LA ROCHE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1997-11-07Nov 7, 1997NoYesNoDISCNHOFFMANN LA ROCHE INCa41fcef4f90790f6adff1f8fe4e22f826734b3e450284877043de805c4ea7732
3154N212904001TIVOZANIB HYDROCHLORIDECAPSULE;ORALCAPSULEORALFOTIVDAAVEO PHARMSEQ 0.89MG BASE[]2021-03-10Mar 10, 2021NoYesNoRXAVEO PHARMACEUTICALS INC12b6219fdae92099e1811eeb094d30613bd138b763602ef6a9d42740de9c5194
3155N212904002TIVOZANIB HYDROCHLORIDECAPSULE;ORALCAPSULEORALFOTIVDAAVEO PHARMSEQ 1.34MG BASE[]2021-03-10Mar 10, 2021NoYesYesRXAVEO PHARMACEUTICALS INC6bab692b52f5e04672ee4d2cd6fbc1a0d4834ff0e5dcea9e0d3ec1adb9aad213
3156A206943001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINACI HEALTHCARE LTD100MGAB["AB"]2018-05-14May 14, 2018NoNoNoRXACI HEALTHCARE LTDb8957be12559263168d53919862acd1624a9eaa7d6f8286083b2448791911b2c
3157A206943002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINACI HEALTHCARE LTD300MGAB["AB"]2018-05-14May 14, 2018NoNoNoRXACI HEALTHCARE LTD7f317d77bf17c9cdc7dec690946eb757a95bcf08d685bc0befcd1a37dacc9a59
3158A206943003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINACI HEALTHCARE LTD400MGAB["AB"]2018-05-14May 14, 2018NoNoNoRXACI HEALTHCARE LTD05a5c9544ad55b467d1062cedfc22d69335c5990f38c743e1d727d208932a314
3159A075350001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINACTAVIS ELIZABETH100MGAB["AB"]2003-09-12Sep 12, 2003NoNoNoRXACTAVIS ELIZABETH LLC75004ee6510707c52a2a6743d77c7729b1518ed5c4bcda3c8345082912c425ca
3160A075350002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINACTAVIS ELIZABETH300MGAB["AB"]2003-09-12Sep 12, 2003NoNoNoRXACTAVIS ELIZABETH LLCca1b05478b753a0f6aa5c3431cea7cfe6c1796a6cb880da25dd0d759b91dd33a
3161A075350003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINACTAVIS ELIZABETH400MGAB["AB"]2003-09-12Sep 12, 2003NoNoNoRXACTAVIS ELIZABETH LLC53bc64c0e02486f55e58603c66ad7febaaac101ec2761702fddee991f8765dc8
3162A090858001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINALKEM100MGAB["AB"]2010-12-17Dec 17, 2010NoNoNoRXALKEM LABORATORIES LTDb4d5ce98878e3f22380cb008d3c194baa9895f450ce4653b14a669820c8705c8
3163A090858002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINALKEM300MGAB["AB"]2010-12-17Dec 17, 2010NoNoNoRXALKEM LABORATORIES LTD8637798c71b034faf9bba2f4266b3b6ea97c7810c04784a9d9909ab845e1cbb9
3164A090858003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINALKEM400MGAB["AB"]2010-12-17Dec 17, 2010NoNoNoRXALKEM LABORATORIES LTDa58a8c345ad1e4dbbc32470babd1667e3b331b30970473e90a5fc741c13e5292
3165A078428001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINAMNEAL PHARMS NY100MGAB["AB"]2007-07-25Jul 25, 2007NoNoNoRXAMNEAL PHARMACEUTICALS NY LLCeeb386fdb19da09a68a5ad7b6fcf44f94c946dc7046b92e6352dea0b65d557b8
3166A078428002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINAMNEAL PHARMS NY300MGAB["AB"]2007-07-25Jul 25, 2007NoNoNoRXAMNEAL PHARMACEUTICALS NY LLCee6c10ab122734c993c570dd76e8043379f5d3ae4b5af4d6f13df4916e3501e6
3167A078428003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINAMNEAL PHARMS NY400MGAB["AB"]2007-07-25Jul 25, 2007NoNoNoRXAMNEAL PHARMACEUTICALS NY LLC199446db2d5a881a5d99543f1134530300ee4c0a7b53ca6deb0304e46c00dc25
3168A078787001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINAUROBINDO PHARMA LTD100MGAB["AB"]2008-01-31Jan 31, 2008NoNoNoRXAUROBINDO PHARMA LTD765f907f0a4b0f8924620c3f2d32cc1beac05a17d2dc024fa4c997d0a03650ff
3169A078787002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINAUROBINDO PHARMA LTD300MGAB["AB"]2008-01-31Jan 31, 2008NoNoNoRXAUROBINDO PHARMA LTDdc35c94d7b376efec5d07329b820f1d9fcdedc2b09b66b0178916c7a530127fd
3170A078787003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINAUROBINDO PHARMA LTD400MGAB["AB"]2008-01-31Jan 31, 2008NoNoNoRXAUROBINDO PHARMA LTD50c61a6fa1e74fb37bd7e1d895a0274f1e2c91e92ca7edaa96908c6a459b6389
3171A075477001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINCSPC OUYI100MGAB["AB"]2005-03-23Mar 23, 2005NoNoNoRXCSPC OUYI PHARMACEUTICAL CO LTD6c7796884e995f5a2e54eb6b1d946ccec6d872457f262bd690f788bc054241ba
3172A075477002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINCSPC OUYI300MGAB["AB"]2005-03-23Mar 23, 2005NoNoNoRXCSPC OUYI PHARMACEUTICAL CO LTD17d538c6a5a08aeadc6da5baa24fe07eba7f62ec5ae97d0a700d2ce42ebe8f32
3173A075477003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINCSPC OUYI400MGAB["AB"]2005-03-23Mar 23, 2005NoNoNoRXCSPC OUYI PHARMACEUTICAL CO LTDe344938c497128ce7fff7218df5ec63faf4a969c75476385e7abf38aa7d093d2
3174A207099001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINEPIC PHARMA LLC100MGAB["AB"]2017-03-24Mar 24, 2017NoNoNoRXEPIC PHARMA LLCe2a3161cd65092f1305999d05514b223941313e9a907321734399ffeb828e073
3175A207099002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINEPIC PHARMA LLC300MGAB["AB"]2017-03-24Mar 24, 2017NoNoNoRXEPIC PHARMA LLC9d2e1b0d40dfd8739d85845706b8942637cf0bc546f6e92ee85f07e6dd958f66
3176A207099003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINEPIC PHARMA LLC400MGAB["AB"]2017-03-24Mar 24, 2017NoNoNoRXEPIC PHARMA LLC9937240880ec6359690a14738f12883779e675e43f3b1595c6ce37201fe953ed
3177A075360001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINGRANULES100MGAB["AB"]2005-04-06Apr 6, 2005NoNoNoRXGRANULES INDIA LTD63755be35af9f01018961c3a07788703ec724b0b8884a7391ad295c4b72d14fb
3178A075360002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINGRANULES300MGAB["AB"]2005-04-06Apr 6, 2005NoNoNoRXGRANULES INDIA LTDbff869da3e561ecd50669d420e396c4ad72d7b4f813e5bb90d71d0c6e4991b87
3179A075360003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINGRANULES400MGAB["AB"]2005-04-06Apr 6, 2005NoNoNoRXGRANULES INDIA LTDba1245ff68875a76eb598a9f7e957451b08d54a6fda9f1038c5b7bf2a9eb109b
3180A078150001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINHIKMA100MG[]2007-09-25Sep 25, 2007NoNoNoDISCNHIKMA PHARMACEUTICALS5f36df0126b6060761fe64d61faebf9d4219f1f6a2d4e261ca35cd8b5cbac027
3181A078150002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINHIKMA300MG[]2007-09-25Sep 25, 2007NoNoNoDISCNHIKMA PHARMACEUTICALSd4dc7df14893bbe711bbe88a8f3192496d532ba77511f81910b752270942dded
3182A078150003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINHIKMA400MG[]2007-09-25Sep 25, 2007NoNoNoDISCNHIKMA PHARMACEUTICALS262226b0a7d34ee0671ae4bfd95cc9df51341bc7af47c4274693364844ef108e
3183A090705001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTININVAGEN PHARMS100MGAB["AB"]2009-12-30Dec 30, 2009NoNoNoRXINVAGEN PHARMACEUTICALS INCd9cb0eb5d071c706b3051ec8625ac9206bc1201a816cb6b7af9c96a17703dc48
3184A090705002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTININVAGEN PHARMS300MGAB["AB"]2009-12-30Dec 30, 2009NoNoNoRXINVAGEN PHARMACEUTICALS INCb60b70f4fee3e9421c78365e6505d1c6fe62746911292677ce45825fa669e919
3185A090705003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTININVAGEN PHARMS400MGAB["AB"]2009-12-30Dec 30, 2009NoNoNoRXINVAGEN PHARMACEUTICALS INC7a98090809dc77c71e0c18fddd34ba05e33497dabf16117a146eaf4473c20eee
3186A091008001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINJIANGSU HENGRUI MED100MG[]2017-10-26Oct 26, 2017NoNoNoDISCNJIANGSU HENGRUI MEDICINE CO LTD60e34ff7ac6f0e835ac4ea4c38c654876759263a18be6ce8b911db2afdc8d89f
3187A091008002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINJIANGSU HENGRUI MED300MG[]2017-10-26Oct 26, 2017NoNoNoDISCNJIANGSU HENGRUI MEDICINE CO LTDd73ab258f5017eb2f01d2450a6dcd95ff8fab0b7d28fa6a4bdd9a39c59234c3b
3188A091008003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINJIANGSU HENGRUI MED400MG[]2017-10-26Oct 26, 2017NoNoNoDISCNJIANGSU HENGRUI MEDICINE CO LTDc551223982fb5e7fe1cb8b1a483a391e911c1744221cab46d6749cc959d2f784
3189A090007001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINMARKSANS PHARMA100MGAB["AB"]2011-07-21Jul 21, 2011NoNoNoRXMARKSANS PHARMA LTD182b7c802f2fe5c5c5da34f9a3328987c2685f262624a450341882faa12fe51c
3190A090007002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINMARKSANS PHARMA300MGAB["AB"]2011-07-21Jul 21, 2011NoNoNoRXMARKSANS PHARMA LTD73969c0c10b5ae4bda6eedb559d49a38197eccd6c09cba4d043571a0643b4231
3191A090007003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINMARKSANS PHARMA400MGAB["AB"]2011-07-21Jul 21, 2011NoNoNoRXMARKSANS PHARMA LTD623a5ef3fef97563994f28b503e756b956657df5b237f89428f298cda55915e2
3192A090158001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINMYLAN100MG[]2011-02-14Feb 14, 2011NoNoNoDISCNMYLAN PHARMACEUTICALS INC9b1fb355e39329b4fa30e8ae9667cb2f0280213876bb5087a96593a4ad256805
3193A090158002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINMYLAN300MG[]2011-02-14Feb 14, 2011NoNoNoDISCNMYLAN PHARMACEUTICALS INCa236c371aeee7f3130a5b206db1121eead97223320df44191c1c29cfacd1b365
3194A090158003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINMYLAN400MG[]2011-02-14Feb 14, 2011NoNoNoDISCNMYLAN PHARMACEUTICALS INCfd0943661e32e7a2ff95be2181f2889aac2b217541b4a8154b27c526ae4c092a
3195A075428001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSANDOZ100MG[]2006-01-24Jan 24, 2006NoNoNoDISCNSANDOZ INC607b6fe7c95867da9f9bdb1b5fdf329c909a0b7028961b7df09aaac3d751341a
3196A075539001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSANDOZ100MG[]2005-04-06Apr 6, 2005NoNoNoDISCNSANDOZ INCb8e92b8f738388dd8bafd25dbdecef6d021016db52cdd5cf32cb4fcdaf3b142b
3197A075428002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSANDOZ300MG[]2006-01-24Jan 24, 2006NoNoNoDISCNSANDOZ INCc92e6b96d5a2f85aa0abc266d1a7b772ddea7b14951caff96cbadfd566454bb5
3198A075539002GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSANDOZ300MG[]2005-04-06Apr 6, 2005NoNoNoDISCNSANDOZ INC55561bc47b72bc685d872486f4fa1eb329f8d32c2a462ccef178931a7ce48111
3199A075428003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSANDOZ400MG[]2006-01-24Jan 24, 2006NoNoNoDISCNSANDOZ INC4cfc97e81e8dae62bf63e8b4d7128e6880a47789652f555f0d616ba2d3aac6bb
3200A075539003GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSANDOZ400MG[]2005-04-06Apr 6, 2005NoNoNoDISCNSANDOZ INC9de856a111031ec1a5f9f2af40864d4f53cfefd4b1b20912ce5e06443a812f0a
3201A204989001GABAPENTINCAPSULE;ORALCAPSULEORALGABAPENTINSCIEGEN PHARMS INC100MGAB["AB"]2016-02-18Feb 18, 2016NoNoNoRXSCIEGEN PHARMACEUTICALS INC7299fe19a9dc850c097b6b620c06826d6b9cbdd76c0f694572df99ada334bc09