← Snapshot 21

Orange Book snapshot 21: Products

Products page 73 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
3602A090695001LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXAPINE SUCCINATELANNETT CO INCEQ 5MG BASEAB["AB"]2011-09-26Sep 26, 2011NoNoNoRXLANNETT CO INCdb9269a69ecb7dfefeed9c94b71d4d9821fdc6853ffef835d63298ee28559128
3603A090695002LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXAPINE SUCCINATELANNETT CO INCEQ 10MG BASEAB["AB"]2011-09-26Sep 26, 2011NoNoNoRXLANNETT CO INC0b16911555ef13b8738a1c6cb8fe9dfad618bf5272a27c321726be68e0d7bd6a
3604A090695003LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXAPINE SUCCINATELANNETT CO INCEQ 25MG BASEAB["AB"]2011-09-26Sep 26, 2011NoNoNoRXLANNETT CO INC733bf56a5b9bd67ece52cd767066f49f69d10644e37c82f28f51c51f32bb1a38
3605A090695004LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXAPINE SUCCINATELANNETT CO INCEQ 50MG BASEAB["AB"]2011-09-26Sep 26, 2011NoNoNoRXLANNETT CO INC1227e06979983bdc5e9445c39b2fee74372c15cc6f9429b1f69e8faa51082443
3606A076762001LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXAPINE SUCCINATEMYLANEQ 5MG BASEAB["AB"]2004-11-01Nov 1, 2004NoNoNoRXMYLAN PHARMACEUTICALS INC2791064f13e1dc76c562edb1e99bd7d5649ca3713c575a5e0e1e1007647dba4c
3607A076762002LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXAPINE SUCCINATEMYLANEQ 10MG BASEAB["AB"]2004-11-01Nov 1, 2004NoNoNoRXMYLAN PHARMACEUTICALS INCd223a7bbaf4ea56ab8ac1333909b865a58cfe7015d1ade0e773e76250db921e4
3608A076762003LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXAPINE SUCCINATEMYLANEQ 25MG BASEAB["AB"]2004-11-01Nov 1, 2004NoNoNoRXMYLAN PHARMACEUTICALS INCef2142c2ac91c1f3b427b4257a5d0c326d77dacdab786f9be10106f7ee9c4935
3609A076762004LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXAPINE SUCCINATEMYLANEQ 50MG BASEAB["AB"]2004-11-01Nov 1, 2004NoNoNoRXMYLAN PHARMACEUTICALS INC42cae65d9530769f2ed206c3cb34c73721b055ef52bc4499d710f49b140c0ab0
3610A072204001LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXAPINE SUCCINATEWATSON LABSEQ 5MG BASEAB["AB"]1988-06-15Jun 15, 1988NoNoNoRXWATSON LABORATORIES INC66b57111fb1d6704c899b793236b9ad4b12d18c89e9cae8375184645cef4f40b
3611A072205001LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXAPINE SUCCINATEWATSON LABSEQ 10MG BASEAB["AB"]1988-06-15Jun 15, 1988NoNoNoRXWATSON LABORATORIES INC5debe6e1b73ae8c0488b3462ad362aa5ad4e8b2777694105e88612d1939dd2bd
3612A072206001LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXAPINE SUCCINATEWATSON LABSEQ 25MG BASEAB["AB"]1988-06-15Jun 15, 1988NoNoYesRXWATSON LABORATORIES INCe50fd67c00ab0307e3d9994d22e78aff1f31f0ba03e6004153576a8d218c553a
3613A072062001LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXAPINE SUCCINATEWATSON LABSEQ 50MG BASEAB["AB"]1988-06-15Jun 15, 1988NoNoNoRXWATSON LABORATORIES INC6b83b5e398d22647f0d71365e11ec9efe2643a6fad0705934dafcd75b2edd03f
3614N017525001LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXITANETEVA BRANDED PHARMEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC344bf3f853e9a01c60aa3bd37cfba039127efe86b158c0a95424614da78db713
3615N017525002LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXITANETEVA BRANDED PHARMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INCc7162af456b1628c4ba368a21a0baedc2e481f7f8202fff9da700ce72c30417b
3616N017525003LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXITANETEVA BRANDED PHARMEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC13a2e8f680e9cb0604ee6cb8814dcd3f1d6a14ddd1a488b0d4b530e2a06ec755
3617N017525004LOXAPINE SUCCINATECAPSULE;ORALCAPSULEORALLOXITANETEVA BRANDED PHARMEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC124e285080cbf84e06d5434973952ee0eba622a625085a02416515eb85c48197
3618N213716001VOCLOSPORINCAPSULE;ORALCAPSULEORALLUPKYNISAURINIA7.9MG[]2021-01-22Jan 22, 2021NoYesYesRXAURINIA PHARMACEUTICALS INCe1895826017f61593904e0cf7a50ccb9dfdb10ac4cb06bdbff8dcf4380d6f9b3
3619A085107001CHLORDIAZEPOXIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALLYGENALRA5MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNALRA LABORATORIES INCe69d19fc4393d4c3711f0b69f86fdfd19b2d0b39b83496865df9a3b6fe76aff3
3620A085009001CHLORDIAZEPOXIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALLYGENALRA10MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNALRA LABORATORIES INCe623e533fc097aad1cd0cd3797cf13c3b4efc2e87803ef0430a1b3efb756db48
3621A085108001CHLORDIAZEPOXIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALLYGENALRA25MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNALRA LABORATORIES INC402afd3dfbad6c1498582f0458a3312a75bcf24adc8831ee07fddd4d9346c073
3622N206162001OLAPARIBCAPSULE;ORALCAPSULEORALLYNPARZAASTRAZENECA50MG[]2014-12-19Dec 19, 2014NoYesNoDISCNASTRAZENECA PHARMACEUTICALS LP0e456f1f8d51ab333a4b1cb8c67df11ace2e4c340384e700e93a0b6fc4bf1994
3623N021446001PREGABALINCAPSULE;ORALCAPSULEORALLYRICAPFIZER25MGAB["AB"]2004-12-30Dec 30, 2004NoYesNoRXPFIZER PFE US HOLDINGS 4 LLC09e3ff8ce5dde490cb58b7a0de87b34f751e973fb2daabfc812fc303c7a6b284
3624N021446002PREGABALINCAPSULE;ORALCAPSULEORALLYRICAPFIZER50MGAB["AB"]2004-12-30Dec 30, 2004NoYesNoRXPFIZER PFE US HOLDINGS 4 LLC5c69fa9d08dfd0690280bf04bd64d03b5332c86793d4d1f092bd3aae0a0b093f
3625N021446003PREGABALINCAPSULE;ORALCAPSULEORALLYRICAPFIZER75MGAB["AB"]2004-12-30Dec 30, 2004NoYesNoRXPFIZER PFE US HOLDINGS 4 LLC8964b3b3b357e47d08436f197f1e7121d952752cfe15ab57541d0a565d191f82
3626N021446004PREGABALINCAPSULE;ORALCAPSULEORALLYRICAPFIZER100MGAB["AB"]2004-12-30Dec 30, 2004NoYesNoRXPFIZER PFE US HOLDINGS 4 LLC7b688f3b51d00a5e6712742aa335b4665ef8c8a238d42ddd0b84e7b09a387e92
3627N021446005PREGABALINCAPSULE;ORALCAPSULEORALLYRICAPFIZER150MGAB["AB"]2004-12-30Dec 30, 2004NoYesNoRXPFIZER PFE US HOLDINGS 4 LLCa97549231738f49e0db8169432fe9a438a309d15dbe3728dbb678871a01495b8
3628N021446006PREGABALINCAPSULE;ORALCAPSULEORALLYRICAPFIZER200MGAB["AB"]2004-12-30Dec 30, 2004NoYesNoRXPFIZER PFE US HOLDINGS 4 LLCc20c32bf7331e9f3cc841d743511ad7626cf9adf74e46e2133ad57c99b8b5d6f
3629N021446007PREGABALINCAPSULE;ORALCAPSULEORALLYRICAPFIZER225MGAB["AB"]2004-12-30Dec 30, 2004NoYesNoRXPFIZER PFE US HOLDINGS 4 LLC3700d3fbb625827226d89ee6459b20af8d6e527ed0c064934e7e9d440e875fc7
3630N021446008PREGABALINCAPSULE;ORALCAPSULEORALLYRICAPFIZER300MGAB["AB"]2004-12-30Dec 30, 2004NoYesYesRXPFIZER PFE US HOLDINGS 4 LLC9734fffb991482500d5eb66765b9482bae44cf685d83cbebf33e42d24b8f6fb1
3631N020064001NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORALCAPSULEORALMACROBIDALMATICA75MG;25MGAB["AB"]1991-12-24Dec 24, 1991NoYesYesRXALMATICA PHARMA LLC5ce1363370a1790e96280e6edca02d163eebd32163f51ebc6957eb6a70d9e597
3632N016620003NITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORALCAPSULEORALMACRODANTINALMATICA25MGAB["AB"]Approved Prior to Jan 1, 1982YesYesNoRXALMATICA PHARMA LLCa56143640a650d444865eaa569e2d7df8bce76615d67078704af3a49bd0feb35
3633N016620001NITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORALCAPSULEORALMACRODANTINALMATICA50MGAB["AB"]Approved Prior to Jan 1, 1982YesYesNoRXALMATICA PHARMA LLC9b5f569e7cd673f29ef21e4a09376d49184548c857a27b4b12bece8b963b181f
3634N016620002NITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORALCAPSULEORALMACRODANTINALMATICA100MGAB["AB"]Approved Prior to Jan 1, 1982YesYesYesRXALMATICA PHARMA LLCb1abff14773c9202508d2d30677a096197d812e0bdc82e490213e7846f69a08c
3635N018651001DRONABINOLCAPSULE;ORALCAPSULEORALMARINOLALKEM LABS LTD2.5MGAB["AB"]1985-05-31May 31, 1985NoYesNoRXALKEM LABORATORIES LTD5d722b36c1fcc47c67647500a0e8928b55ff600c728d6c2f6af0c3a6a3955dbc
3636N018651002DRONABINOLCAPSULE;ORALCAPSULEORALMARINOLALKEM LABS LTD5MGAB["AB"]1985-05-31May 31, 1985NoYesYesRXALKEM LABORATORIES LTD184bb80c89fdedbaac83dddd58b232e8c83484ad140f07e9db1215587d660cee
3637N018651003DRONABINOLCAPSULE;ORALCAPSULEORALMARINOLALKEM LABS LTD10MGAB["AB"]1985-05-31May 31, 1985NoYesNoRXALKEM LABORATORIES LTDc1f10bdbab387451348b55069ce9805284cb85216c31b40f223b56f789eb67f5
3638N016785001PROCARBAZINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMATULANELEADIANT BIOSCI INCEQ 50MG BASE[]Approved Prior to Jan 1, 1982YesYesYesRXLEADIANT BIOSCIENCES INCb99c1aa881809f64864869f6d238baa62bd324ff0edb26f043c8630d5dcea3ee
3639A071380001MECLOFENAMATE SODIUMCAPSULE;ORALCAPSULEORALMECLODIUMQUANTUM PHARMICSEQ 50MG BASE[]1987-07-14Jul 14, 1987NoNoNoDISCNQUANTUM PHARMICS LTDdec8414ce0cb339be5495ccccb41daf9e82830fcf6d82502a4fa69f4b0b08b76
3640A071381001MECLOFENAMATE SODIUMCAPSULE;ORALCAPSULEORALMECLODIUMQUANTUM PHARMICSEQ 100MG BASE[]1987-07-14Jul 14, 1987NoNoNoDISCNQUANTUM PHARMICS LTD74da668bb462e783a4022dc8e1fc21c369e6c515043ac63b675281b2ad2d8834
3641A071362001MECLOFENAMATE SODIUMCAPSULE;ORALCAPSULEORALMECLOFENAMATE SODIUMAM THERAPEQ 50MG BASE[]1987-02-10Feb 10, 1987NoNoNoDISCNAMERICAN THERAPEUTICS INC09b40d570366c76b33446922695238dc0e8639b02bc831fba2f8dbb4cc691548
3642A071363001MECLOFENAMATE SODIUMCAPSULE;ORALCAPSULEORALMECLOFENAMATE SODIUMAM THERAPEQ 100MG BASE[]1987-02-10Feb 10, 1987NoNoNoDISCNAMERICAN THERAPEUTICS INC636951b22ef3624d3e98a295ac750ba6a5461580c89801bc6b0158b238935982
3643A071469002MECLOFENAMATE SODIUMCAPSULE;ORALCAPSULEORALMECLOFENAMATE SODIUMANI PHARMS INCEQ 50MG BASE[]1987-04-15Apr 15, 1987NoNoNoDISCNANI PHARMACEUTICALS INCcc5dc8c5608768e96219cee66365865ac491b8a81aedb30f0251bed91a8fe5df
3644A071469001MECLOFENAMATE SODIUMCAPSULE;ORALCAPSULEORALMECLOFENAMATE SODIUMANI PHARMS INCEQ 100MG BASE[]1987-04-15Apr 15, 1987NoNoNoDISCNANI PHARMACEUTICALS INCe5ea3f76794ec15195a1fc242d5d69b6fbe9792fc8611d784188516f270cffa1
3645A072848001MECLOFENAMATE SODIUMCAPSULE;ORALCAPSULEORALMECLOFENAMATE SODIUMBARREQ 50MG BASE[]1989-03-20Mar 20, 1989NoNoNoDISCNBARR LABORATORIES INC6b80faf4cfed8cce53bba092f043afe22316a221846df6c65b12e42d34993649
3646A072809001MECLOFENAMATE SODIUMCAPSULE;ORALCAPSULEORALMECLOFENAMATE SODIUMBARREQ 100MG BASE[]1989-03-20Mar 20, 1989NoNoNoDISCNBARR LABORATORIES INCb051004295b97fcc318282e065200110f6d488936acee092901fdce004202f1d
3647A072262001MECLOFENAMATE SODIUMCAPSULE;ORALCAPSULEORALMECLOFENAMATE SODIUMFOSUN PHARMAEQ 50MG BASE[]1988-11-29Nov 29, 1988NoNoNoDISCNFOSUN PHARMA USA INC1be7b14e16892be47d9281ae4ff3243087fff0f7a3b5e57b13e52b731d88d9bb
3648A072263001MECLOFENAMATE SODIUMCAPSULE;ORALCAPSULEORALMECLOFENAMATE SODIUMFOSUN PHARMAEQ 100MG BASE[]1988-11-29Nov 29, 1988NoNoNoDISCNFOSUN PHARMA USA INC67d7bcd83daa608fa3376732e39e05a44b11a311f26bf9d59439d2cd86935f2a
3649A071081002MECLOFENAMATE SODIUMCAPSULE;ORALCAPSULEORALMECLOFENAMATE SODIUMMYLANEQ 50MG BASE[]1986-09-03Sep 3, 1986NoNoNoRXMYLAN PHARMACEUTICALS INC8b0b73fe2ae2c1f7bea3b1b4f25f5e2c086963117bbcee710dd89c0b30fb7644
3650A071081001MECLOFENAMATE SODIUMCAPSULE;ORALCAPSULEORALMECLOFENAMATE SODIUMMYLANEQ 100MG BASE[]1986-09-03Sep 3, 1986NoNoYesRXMYLAN PHARMACEUTICALS INC0eadbd237e5a17ffa9f1cf2f6ed4bd34d84335dc45fe7c7e751dcbe894b45ec8
3651A072077001MECLOFENAMATE SODIUMCAPSULE;ORALCAPSULEORALMECLOFENAMATE SODIUMPAR PHARMEQ 50MG BASE[]1988-03-10Mar 10, 1988NoNoNoDISCNPAR PHARMACEUTICAL INCd0773464593136aff196f442f5f85dce6849b71d68c4a6854005821eb5728ebe