← Snapshot 21

Orange Book snapshot 21: Products

Products page 23 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
1102A202104007MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEUPSHER SMITH LABS100MGAB["AB"]2013-06-03Jun 3, 2013NoNoNoRXUPSHER SMITH LABORATORIES LLC2fcaac75b3915f47d2fbfee9e0e1ab89cc6408df5b00f19d43bcf41e2b5bdf9d
1103N022063001AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMYDAYISTAKEDA PHARMS USA3.125MG;3.125MG;3.125MG;3.125MG[]2017-06-20Jun 20, 2017NoYesNoRXTAKEDA PHARMACEUTICALS USA INC384979c50056273accfaf8db3c45cb3bee57d081b32dde6046e4115b7a762505
1104N022063002AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMYDAYISTAKEDA PHARMS USA6.25MG;6.25MG;6.25MG;6.25MG[]2017-06-20Jun 20, 2017NoYesNoRXTAKEDA PHARMACEUTICALS USA INC0cad2d3fe42c0e0f4e49c442d686cb859d8b3c598c8673eeee7aa076248b06f9
1105N022063003AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMYDAYISTAKEDA PHARMS USA9.375MG;9.375MG;9.375MG;9.375MG[]2017-06-20Jun 20, 2017NoYesNoRXTAKEDA PHARMACEUTICALS USA INCe31bd551a486b7483fb0d802276099c81549822483e71df618fd835f48dbf023
1106N022063004AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMYDAYISTAKEDA PHARMS USA12.5MG;12.5MG;12.5MG;12.5MG[]2017-06-20Jun 20, 2017NoYesYesRXTAKEDA PHARMACEUTICALS USA INC8777f4634e7bce0458b1d131f98e2012af6b62033f10086d279788a9d7d9cf91
1107N022525001MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALNAMENDA XRFOREST LABS LLC7MGAB["AB"]2010-06-21Jun 21, 2010NoYesNoRXFOREST LABORATORIES LLCc2d2f3c8b1528c9cc69aaea8c6f02dd07d7e6b14e0290a6743cff21c919575f3
1108N022525002MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALNAMENDA XRFOREST LABS LLC14MGAB["AB"]2010-06-21Jun 21, 2010NoYesNoRXFOREST LABORATORIES LLCdea6de49916786cf9c9bc0019f0dc52e8ca0044d2fbfb468ee72c661990cb997
1109N022525003MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALNAMENDA XRFOREST LABS LLC21MGAB["AB"]2010-06-21Jun 21, 2010NoYesNoRXFOREST LABORATORIES LLCa7b00e0153bd6d1e3c0df942a4c80b500d94c550e2294d307571f450dff685fb
1110N022525004MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALNAMENDA XRFOREST LABS LLC28MGAB["AB"]2010-06-21Jun 21, 2010NoYesYesRXFOREST LABORATORIES LLCc72182ff7557bb8ac645ebc03b26f306ef62e8ab006d6389a54ee69a3689e248
1111N206439003DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALNAMZARICALLERGAN10MG;7MG[]2016-07-18Jul 18, 2016NoYesNoRXALLERGAN SALES LLC2b5c9e1f62a6b821d7f03591ccb9a723c84062e4d1170ce16504d34ca2440f3a
1112N206439001DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALNAMZARICALLERGAN10MG;14MG[]2014-12-23Dec 23, 2014NoYesNoRXALLERGAN SALES LLC6486107a26675e69642edcbc6dd8a4b0cd8fe60d23527440719b8e40a36717b7
1113N206439004DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALNAMZARICALLERGAN10MG;21MG[]2016-07-18Jul 18, 2016NoYesNoRXALLERGAN SALES LLCef45ae20e5ce30aa6f01f698676ae23ec9be2de7d376a809567186067bfb182a
1114N206439002DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALNAMZARICALLERGAN10MG;28MG[]2014-12-23Dec 23, 2014NoYesYesRXALLERGAN SALES LLC9993cd3ea91cec2eb63f64cd97003b6d7a7611e100e4fcbd89c071adb9acbce7
1115N018655001DISOPYRAMIDE PHOSPHATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALNORPACE CRPFIZEREQ 100MG BASE[]1982-07-20Jul 20, 1982NoYesNoRXPFIZER INC50075633e5b65755ef74900eaff206fc994f564c8aa908b5023031ddd3b96c39
1116N018655002DISOPYRAMIDE PHOSPHATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALNORPACE CRPFIZEREQ 150MG BASE[]1982-07-20Jul 20, 1982NoYesYesRXPFIZER INCe1d09a18fece72e3ccfaae63b05879960ee468cf3b4565f500ef6c63b7decae1
1117N017603001PSEUDOEPHEDRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALNOVAFEDSANOFI AVENTIS US120MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNSANOFI AVENTIS US LLCe10faa04c8d96ff67ba697b008f41f6bf6f7194ee0a8d2d77d50fee2c7388f8e
1118N211929001BUDESONIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALORTIKOSSUN PHARMA GLOBAL6MG[]2019-06-13Jun 13, 2019NoYesNoRXSUN PHARMA GLOBAL FZE82d2d000210fd90cb5809ffaa5689e1174df2099b6e5aef5e6eca30924b10bbf
1119N211929002BUDESONIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALORTIKOSSUN PHARMA GLOBAL9MG[]2019-06-13Jun 13, 2019NoYesYesRXSUN PHARMA GLOBAL FZE0fd20219b31297d36f6dcce21fd71d8bf26ebf24918fce0e36f4f3e24a1a4b13
1120N019816003KETOPROFENCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALORUVAILWYETH PHARMS INC100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1995-02-08Feb 8, 1995NoYesNoDISCNWYETH PHARMACEUTICALS INC5db884252b09c7440964f5908500fdc83df53c04cac19890b15e5d2bb92585ed
1121N019816002KETOPROFENCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALORUVAILWYETH PHARMS INC150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1995-02-08Feb 8, 1995NoYesNoDISCNWYETH PHARMACEUTICALS INCe4f17250f23e2e953844bbfd3bd75c9cf8636dd438678524718b7c9e70067606
1122N019816001KETOPROFENCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALORUVAILWYETH PHARMS INC200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1993-09-24Sep 24, 1993NoYesNoDISCNWYETH PHARMACEUTICALS INCf27f9e13586eed8d08150cbdb6b01c2caae20c5bdd94c032864c89d0d0db426c
1123N021044001HYDROMORPHONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPALLADONEPURDUE PHARMA LP12MG[]2004-09-24Sep 24, 2004NoNoNoDISCNPURDUE PHARMA LP31bf2aff423417c7aab5c0796ae46ed2f7507f719022962781c5db8740db837b
1124N021044002HYDROMORPHONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPALLADONEPURDUE PHARMA LP16MG[]2004-09-24Sep 24, 2004NoNoNoDISCNPURDUE PHARMA LP0eec650ce21329968a5ee8d93070a92615005782fe127b8da8fe1250f315a225
1125N021044003HYDROMORPHONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPALLADONEPURDUE PHARMA LP24MG[]2004-09-24Sep 24, 2004NoNoNoDISCNPURDUE PHARMA LP32a2527c8efcbd62cc2c167e2bef77bc592f2ae299c69827093f1a31d7a39c6a
1126N021044004HYDROMORPHONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPALLADONEPURDUE PHARMA LP32MG[]2004-09-24Sep 24, 2004NoNoNoDISCNPURDUE PHARMA LP413e80dac016092852a08e2b6321c90b468a23fcd94e761d1be9d2a034668f6a
1127N020049001MESALAMINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPENTASATAKEDA PHARMS USA250MG[]1993-05-10May 10, 1993NoYesNoRXTAKEDA PHARMACEUTICALS USA INCce251d16e4dfc6be35f5dc54d8db8c1480e479919928719a6a0c058ca9e11b9c
1128N020049002MESALAMINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPENTASATAKEDA PHARMS USA500MG[]2004-07-08Jul 8, 2004NoYesYesRXTAKEDA PHARMACEUTICALS USA INC26a17581f835b2f4e12fab961a9c553a45cd754de36e4bb2d418d7b50cd55e72
1129A087214001PHENDIMETRAZINE TARTRATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPHENDIMETRAZINE TARTRATEGRAHAM DM105MG[]1982-05-26May 26, 1982NoNoNoDISCNDM GRAHAM LABORATORIES INC33fed3cd58916291be85d9ff94a2699ad7dcb99f57a38d30218e708354b6efbe
1130A088020001PHENDIMETRAZINE TARTRATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPHENDIMETRAZINE TARTRATEGRAHAM DM105MG[]1982-08-16Aug 16, 1982NoNoNoDISCNDM GRAHAM LABORATORIES INC7b7a3ec1d26fd6dd42e2a6c6682da37fd3d9a03fb7ed08692e92864e076ffb56
1131A088028001PHENDIMETRAZINE TARTRATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPHENDIMETRAZINE TARTRATEGRAHAM DM105MG[]1982-08-16Aug 16, 1982NoNoNoDISCNDM GRAHAM LABORATORIES INCa2771c2d09040b8948ec107e8a12a13fb75f79ea2749007e89b9470b4671b77f
1132A088062001PHENDIMETRAZINE TARTRATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPHENDIMETRAZINE TARTRATEGRAHAM DM105MG[]1982-09-13Sep 13, 1982NoNoNoDISCNDM GRAHAM LABORATORIES INC9791fc4f9259b0330b14d81792f313faefdce1500f2c1a10881e75f6ce6e337c
1133A088063001PHENDIMETRAZINE TARTRATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPHENDIMETRAZINE TARTRATEGRAHAM DM105MG[]1982-09-10Sep 10, 1982NoNoNoDISCNDM GRAHAM LABORATORIES INC8e813f9b5e1d9667d37bd56a68d4103f4ae51e04b4020c7e1a74843af25ea626
1134A088111001PHENDIMETRAZINE TARTRATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPHENDIMETRAZINE TARTRATEGRAHAM DM105MG[]1982-10-18Oct 18, 1982NoNoNoDISCNDM GRAHAM LABORATORIES INC6cb0ea114ac768cee976b41408f3bad83d16d802c8eb46f3468f60ac349b56ee
1135A087378001PHENDIMETRAZINE TARTRATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPHENDIMETRAZINE TARTRATEVIRTUS PHARMS105MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNVIRTUS PHARMACEUTICALS LLC2f381d7a5e1476672173bca2aac1173337be00e5d47e422af85331f7cb522c66
1136N018074001PHENDIMETRAZINE TARTRATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPHENDIMETRAZINE TARTRATEVIRTUS PHARMS105MG[]Approved Prior to Jan 1, 1982YesYesYesRXVIRTUS PHARMACEUTICALS LLCadace51d39c915b1c8094c975b70479567ba4f21d9d6f642c9901efd7bbafe0e
1137A089120001PHENTERMINE RESIN COMPLEXCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPHENTERMINE RESIN 30QUANTUM PHARMICSEQ 30MG BASE[]1988-02-04Feb 4, 1988NoNoNoDISCNQUANTUM PHARMICS LTD245957b55989dedb22125de5d872499b81aac33f1003cdd8bdf2b63f341fabaa
1138A040872001PHENTERMINE RESIN COMPLEXCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPHENTERMINE RESIN COMPLEXLANNETT CO INCEQ 15MG BASE[]2011-07-28Jul 28, 2011NoNoNoDISCNLANNETT CO INCe10324a9bf2886519505108f6d05c2072bcc352c493eec3c5a6e7f3625b8c581
1139A040872002PHENTERMINE RESIN COMPLEXCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPHENTERMINE RESIN COMPLEXLANNETT CO INCEQ 30MG BASE[]2011-07-28Jul 28, 2011NoNoNoDISCNLANNETT CO INC90fb7561fa0855d1401039345e55c60fd86193a59a6cdbc5b9cffc15cfa8a0a6
1140N019456001PINACIDILCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPINDACLEO PHARM12.5MG[]1989-12-28Dec 28, 1989NoNoNoDISCNLEO PHARMACEUTICAL PRODUCTS LTD274f961187af7e491732d7d1699e69e55b5503b94544d04670b5ea1d41dd451e
1141N019456002PINACIDILCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPINDACLEO PHARM25MG[]1989-12-28Dec 28, 1989NoNoNoDISCNLEO PHARMACEUTICAL PRODUCTS LTD1b40e29d3ab895ed25aedb42264fc4aa6d25bd3489ce97ee4feadc137280d519
1142A077419001POTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPOTASSIUM CHLORIDEACTAVIS LABS FL INC8MEQAB["AB"]2008-06-02Jun 2, 2008NoNoNoRXACTAVIS LABORATORIES FL INC5d9ca6f9805fb4331812428b86d035c71f4d2b88ecdfee6f2fbdb9d1be54dbc0
1143A077419002POTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPOTASSIUM CHLORIDEACTAVIS LABS FL INC10MEQAB["AB"]2008-06-02Jun 2, 2008NoNoYesRXACTAVIS LABORATORIES FL INC9868694e0b170793511f1dab69b75fa856292670eb984d95c821819de2f7484d
1144A208864001POTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPOTASSIUM CHLORIDEADARE PHARMS INC8MEQAB["AB"]2017-03-17Mar 17, 2017NoNoNoRXADARE PHARMACEUTICALS INC102d4ddf4125bc3a2aa367a8e76e011a7cf93472fac0718711fe20bcdb926794
1145A208864002POTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPOTASSIUM CHLORIDEADARE PHARMS INC10MEQAB["AB"]2017-03-17Mar 17, 2017NoNoNoRXADARE PHARMACEUTICALS INC65cac573e211e6f1c55946f7aa20a615084398852e17f98e71e362d53bca3071
1146A202128001POTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPOTASSIUM CHLORIDEAMNEAL PHARMS10MEQAB["AB"]2013-02-22Feb 22, 2013NoNoNoRXAMNEAL PHARMACEUTICALS1e4ed0576c39c52f2095b679869c6c3e391944c1239fa700ba101ce10ce68b30
1147A202886001POTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPOTASSIUM CHLORIDEANCHEN PHARMS8MEQAB["AB"]2013-12-26Dec 26, 2013NoNoNoRXANCHEN PHARMACEUTICALS INC9a76b3e863b8ff55fe6f773e69b856bf4ab2b198808a102aedecc4428aa1eb66
1148A202886002POTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPOTASSIUM CHLORIDEANCHEN PHARMS10MEQAB["AB"]2013-12-26Dec 26, 2013NoNoNoRXANCHEN PHARMACEUTICALS INCfe4b7bf0ea806152fd0f790b68f1422c6b5176745c9884cb3b99a97d2fd8e9da
1149A202868001POTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPOTASSIUM CHLORIDEGLENMARK PHARMS LTD10MEQAB["AB"]2016-01-19Jan 19, 2016NoNoNoRXGLENMARK PHARMACEUTICALS LTDbc8118eec972ba5672749b772c2c3b5ce48b73a9df315c194aa4a63eba363252
1150A214686001POTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPOTASSIUM CHLORIDEGRANULES8MEQAB["AB"]2021-02-16Feb 16, 2021NoNoNoRXGRANULES INDIA LTD82bad0cd069405b992800442b2449fc57482a13d2e5d4d6efef6fbd9a36a2e8e
1151A214686002POTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPOTASSIUM CHLORIDEGRANULES10MEQAB["AB"]2021-02-16Feb 16, 2021NoNoNoRXGRANULES INDIA LTDab9000c274543a94b8ae5d791058b015a5255d9c7061f064d0c654a4a0c9b9e2