← Snapshot 21

Orange Book snapshot 21: Products

Products page 26 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
1252N203312004CARBIDOPA; LEVODOPACAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRYTARYIMPAX LABS INC61.25MG;245MG[]2015-01-07Jan 7, 2015NoYesYesRXIMPAX LABORATORIES INCe034c61432935e04668eefa1642ecfdb01472505fc10ed10347c606d4c10c944
1253N021416001PROPAFENONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRYTHMOL SRGLAXOSMITHKLINE LLC225MGAB["AB"]2003-09-04Sep 4, 2003NoYesNoRXGLAXOSMITHKLINE LLCf13291ef5e2dd2d53e0740c504a577058adf71481eb53579c57e8460f2d63066
1254N021416002PROPAFENONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRYTHMOL SRGLAXOSMITHKLINE LLC325MGAB["AB"]2003-09-04Sep 4, 2003NoYesNoRXGLAXOSMITHKLINE LLCe53bceebf0c07a3c979473a2c8b8f4ecddeb70ae235e317ccf2f8ec77da05e11
1255N021416003PROPAFENONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRYTHMOL SRGLAXOSMITHKLINE LLC425MGAB["AB"]2003-09-04Sep 4, 2003NoYesYesRXGLAXOSMITHKLINE LLC1ede6aa7254d592d3ddb91122591310835c16b3d9945983333f68f6d9e17afaa
1256N022103001TROSPIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSANCTURA XRALLERGAN60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]2007-08-03Aug 3, 2007NoYesNoDISCNALLERGAN INCc8bfa519e0af4dd2c793440e72d46b604d2019ec48b3ce7c4a3db56a763a2d0d
1257A088269001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSLO-BIDSANOFI AVENTIS US50MG[]1985-01-31Jan 31, 1985NoNoNoDISCNSANOFI AVENTIS US LLC77ca6562a75a674cda4030a974ebe84f4e48c153516335fa68c707ec9c4a9977
1258A089539001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSLO-BIDSANOFI AVENTIS US75MG[]1989-05-10May 10, 1989NoNoNoDISCNSANOFI AVENTIS US LLC5ba6ef328de870657fb4ba91aaa463360dbb335d5b46c1ee4e66c1ac44ad8eba
1259A087892001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSLO-BIDSANOFI AVENTIS US100MG[]1985-01-31Jan 31, 1985NoNoNoDISCNSANOFI AVENTIS US LLCd8c021d48b7ced03a80b66f924224764352a13c4f3d7bbcb20aae6e353533dcc
1260A089540001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSLO-BIDSANOFI AVENTIS US125MG[]1989-05-10May 10, 1989NoNoNoDISCNSANOFI AVENTIS US LLC60a0100ef75a8babc19d87cde6ddb43cc711c9196ce57e6ea4d20e9192030380
1261A087893001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSLO-BIDSANOFI AVENTIS US200MG[]1985-01-31Jan 31, 1985NoNoNoDISCNSANOFI AVENTIS US LLC88320ac6bd313e3d2339cab3406837180a2783fa64a429faf0df63833209d108
1262A087894001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSLO-BIDSANOFI AVENTIS US300MG[]1985-01-31Jan 31, 1985NoNoNoDISCNSANOFI AVENTIS US LLC1e50a2aad1e783ce9c1a29f7594696b20b83ffb9efe52e2ebe36a193d0643396
1263A085206001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSLO-PHYLLINSANOFI AVENTIS US60MG[]1982-05-24May 24, 1982NoNoNoDISCNSANOFI AVENTIS US LLCcf2d4d7e341f3f0d549b8a33541007a08f78128464599acce37b97362b0cc7ff
1264A085203001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSLO-PHYLLINSANOFI AVENTIS US125MG[]1982-05-24May 24, 1982NoNoNoDISCNSANOFI AVENTIS US LLC72cb4e3e8d47dfe1c6b5004fba6e4540184b2b4e8468cdddaa74798944f9001c
1265A085205001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSLO-PHYLLINSANOFI AVENTIS US250MG[]1982-05-24May 24, 1982NoNoNoDISCNSANOFI AVENTIS US LLC6a0a0d4e170c8388e8334d171c30190aae6123498072f24ed4a84649405fb941
1266A087763001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSOMOPHYLLIN-CRTGRAHAM DM50MG[]1985-02-27Feb 27, 1985NoNoNoDISCNDM GRAHAM LABORATORIES INCf0a1af6676c09004e4b563f45893a7da49ef56e3e9bd00e127708335fc1d087d
1267A087194001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSOMOPHYLLIN-CRTGRAHAM DM100MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNDM GRAHAM LABORATORIES INC04e286c7ad103d802b287a262207c27de4272810b493eeea8323ee9fefad819d
1268A088382001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSOMOPHYLLIN-CRTGRAHAM DM200MG[]1985-02-27Feb 27, 1985NoNoNoDISCNDM GRAHAM LABORATORIES INC61add37e72b86ef241e63c61519275ff676ec0f00a671ff587f1204aa074c84e
1269A087193001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSOMOPHYLLIN-CRTGRAHAM DM250MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNDM GRAHAM LABORATORIES INC37de1dab397fd1d3b7ccc45d3cea0baf22ac11794f3ae0b3c738562676231707
1270A088383001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSOMOPHYLLIN-CRTGRAHAM DM300MG[]1985-02-27Feb 27, 1985NoNoNoDISCNDM GRAHAM LABORATORIES INC8cda056c8ffbe60fc7f98a33a8e206f7b8a9362ebb8d040f56b5b657f37befbd
1271A088024001PHENDIMETRAZINE TARTRATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSPRX-105NUMARK105MG[]1982-12-22Dec 22, 1982NoNoNoDISCNNUMARK LABORATORIES INCc50606647c808ee709b791341a6384bc0345add83642d6eb0017caaf56709937
1272N017941002PSEUDOEPHEDRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALSUDAFED 12 HOURGLAXOSMITHKLINE120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNGLAXOSMITHKLINE1c07a9a1a8546df3c52a28f37aa475de3b4217ee732c7275d8b17ec9909d3773
1273A075401001DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTAZTIA XTACTAVIS LABS FL INC120MGAB4["AB4"]2003-04-10Apr 10, 2003NoNoNoRXACTAVIS LABORATORIES FL INCbbf31f5823d514faaed5298376fc196851f88f22e2bc1363347d61fbe62a419e
1274A075401002DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTAZTIA XTACTAVIS LABS FL INC180MGAB4["AB4"]2003-04-10Apr 10, 2003NoNoNoRXACTAVIS LABORATORIES FL INCdb3c8176e3dc9c6d27f52f25fc8116fc296c7a163eca0ad896a3692c9ffd2079
1275A075401003DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTAZTIA XTACTAVIS LABS FL INC240MGAB4["AB4"]2003-04-10Apr 10, 2003NoNoNoRXACTAVIS LABORATORIES FL INCf507872e33bb89efaa4b6ba9741cfd273d3c8929e430fa4dc8e4c7989b40a8df
1276A075401004DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTAZTIA XTACTAVIS LABS FL INC300MGAB4["AB4"]2003-04-10Apr 10, 2003NoNoNoRXACTAVIS LABORATORIES FL INC525273d68cea6c9c572463bbe39a1ab84fdc8ba5dbf7ed213f1c3d47c4dd8890
1277A075401005DILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTAZTIA XTACTAVIS LABS FL INC360MGAB4["AB4"]2003-04-10Apr 10, 2003NoNoNoRXACTAVIS LABORATORIES FL INC0aea294a755e9ef9711705ef99f141a74fa5d71f4e43f6ca3049cb1501eac6c2
1278N017369001CHLORPHENIRAMINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTELDRINGLAXOSMITHKLINE8MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNGLAXOSMITHKLINE5dc8930d9eb9d4eb781ea4c89dcebc00ad4a788bf67e1096f6f6c0acbd7a98dc
1279N017369002CHLORPHENIRAMINE MALEATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTELDRINGLAXOSMITHKLINE12MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNGLAXOSMITHKLINE2b5bced001d0d88d23698e334e4b41e8c8a25dc8874eba93d643b2ed22b5081e
1280N011316004TRIMEPRAZINE TARTRATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTEMARILALLERGAN HERBERTEQ 5MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC769409491dd3e7c70819ba07b557a3e95a7b7a909bf722a699fdd61aead2a330
1281A087942001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEO-24ACTIENT PHARMS100MG[]1983-08-22Aug 22, 1983NoNoNoRXACTIENT PHARMACEUTICALS LLCa7cf038f9ed3a74d94f61072f82bd98e4c3e0199f3f4b5ee2d60c14a135d7c60
1282A081034001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEO-24AUXILIUM PHARMS INC400MG[]1992-02-28Feb 28, 1992NoNoYesRXAUXILIUM PHARMACEUTICALS INCd44183179aff6ebfa026f39fd273b489083bdd18f2ddfe59bff3e7668be5802c
1283A087943001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEO-24AUXILIUM PHARMS LLC200MG[]1983-08-22Aug 22, 1983NoNoNoRXAUXILIUM PHARMACEUTICALS LLCc20408ec427a1e452c4bd1d78d28a1eb28d73850aefb559959d31caf3915c75b
1284A087944001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEO-24AUXILIUM PHARMS LLC300MG[]1983-08-22Aug 22, 1983NoNoNoRXAUXILIUM PHARMACEUTICALS LLC37d1b6e3ff4c99204587ada40acc632153412d194920bf0ea5e933c8431e2e83
1285A088022001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEO-DURSCHERING50MG[]1985-09-10Sep 10, 1985NoNoNoDISCNSCHERING CORP0d9fced1a5ecd9a32c32db22725841889e1710570cbfa1453f15da75f7c7570d
1286A088015001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEO-DURSCHERING75MG[]1985-09-10Sep 10, 1985NoNoNoDISCNSCHERING CORP12853c1666fabc2f97e500665d14075150f20b183fd6a279f0fc56c2feb8ea89
1287A088016001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEO-DURSCHERING125MG[]1985-09-10Sep 10, 1985NoNoNoDISCNSCHERING CORP010d1ae991578149325677023a4551b0c7fed52bc207e969abc4720c5f12bf66
1288A087995001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEO-DURSCHERING200MG[]1985-09-10Sep 10, 1985NoNoNoDISCNSCHERING CORP23e8db621eeee3d923ed83af8a5436e669e31ff4e0eab83b38de3a2ef0b57ee9
1289A085983001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEOBIDWHITBY260MG[]1985-03-20Mar 20, 1985NoNoNoDISCNWHITBY PHARMACEUTICALS INCffe32eef6ffbbfc39d4951fecf2ce153f5e3c507cf84dcb3e533ae2e721c0326
1290A087854001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEOBID JR.WHITBY130MG[]1985-03-20Mar 20, 1985NoNoNoDISCNWHITBY PHARMACEUTICALS INCdc182686a21d2313866f072d0cd0d057e9d3b7682c316931ab7ff00945895686
1291A086569001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEOCLEAR L.A.-130SCHWARZ PHARMA130MG[]1982-05-27May 27, 1982NoNoNoDISCNSCHWARZ PHARMA INC7525318ee0fb828e53f018d468aae37b24f3401d1b72a7afff4cc9cd9a8d579c
1292A086569002THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEOCLEAR L.A.-260SCHWARZ PHARMA260MG[]1982-05-27May 27, 1982NoNoNoDISCNSCHWARZ PHARMA INC26c0488fd710d6978aff57a4551b4bb810c074090b6f0890e2bb6fe373770cd6
1293A086480001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEOPHYL-SRORTHO MCNEIL PHARM125MG[]1985-02-08Feb 8, 1985NoNoNoDISCNORTHO MCNEIL PHARMACEUTICAL INCffc59032dd5554212fd3298accaa9f42b099bb25fddc4001d34bba40f0765542
1294A086471001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEOPHYL-SRORTHO MCNEIL PHARM250MG[]1985-02-08Feb 8, 1985NoNoNoDISCNORTHO MCNEIL PHARMACEUTICAL INCf226089cd2c92118f8a25caa70cd1d7de948c960ffd216e24c5b08f5a927667c
1295A088654001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEOPHYLLINECENT PHARMS125MG[]1985-02-12Feb 12, 1985NoNoNoDISCNCENTRAL PHARMACEUTICALS INC915b1ad79854cc88f721796ffc72a7ac50b4bfba569b3fad465cdd9045181639
1296A088689001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEOPHYLLINECENT PHARMS250MG[]1985-02-12Feb 12, 1985NoNoNoDISCNCENTRAL PHARMACEUTICALS INCcfdde50fdb589327e2ae702e13008791bc9ab7c710957353ba24aba3624b0d55
1297A089976001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEOPHYLLINEHOSPIRA100MG[]1995-01-04Jan 4, 1995NoNoNoDISCNHOSPIRA INCd9e72ea461aa355a6501f6ce6faf4a85713cd29451c6db1ad8138bbd785963df
1298A089977001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEOPHYLLINEHOSPIRA200MG[]1995-01-04Jan 4, 1995NoNoNoDISCNHOSPIRA INC3222172f9ffc59329abed7d1e2d46694176aa88c1eef76e5dd33ff8fdf1ac216
1299A089932001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEOPHYLLINEHOSPIRA300MG[]1995-01-04Jan 4, 1995NoNoNoDISCNHOSPIRA INC3169c18340d5438eed89ec7a641fe54c9b45abc3b1936eacc56fb6fc423f81bf
1300A040052001THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEOPHYLLINEINWOOD LABS100MG[]1994-02-14Feb 14, 1994NoNoNoDISCNINWOOD LABORATORIES INC SUB FOREST LABORATORIES INC8f69be1411da48483d9e56c5d5ea303b55c71d21476385d8bda4b55daf85e1c8
1301A040052002THEOPHYLLINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALTHEOPHYLLINEINWOOD LABS125MG[]1994-02-14Feb 14, 1994NoNoNoDISCNINWOOD LABORATORIES INC SUB FOREST LABORATORIES INCf89d57a2d8ad7bb77f46983b91bbbe77df7d79eb0a8c011ca18a55e8a116c5b4