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← Snapshot 21

Orange Book snapshot 21: Products

Products page 68 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
3352A211344002IBRUTINIBCAPSULE;ORALCAPSULEORALIBRUTINIBZYDUS140MGAB["AB"]2021-03-31Mar 31, 2021NoNoNoRXZYDUS WORLDWIDE DMCC017fd467583a14f4c68e887a7fb575c2fccc195ea4696e7a7a2cdbf44ed77f42
3353A202300001IBUPROFENCAPSULE;ORALCAPSULEORALIBUPROFENAMNEAL PHARMSEQ 200MG FREE ACID AND POTASSIUM SALT[]2011-12-23Dec 23, 2011NoNoNoOTCAMNEAL PHARMACEUTICALS OF NEW YORK LLC7b1a6750ef7f75428b01c2a7a05712638c57531dda48b24171504eb880fba6e8
3354A206999001IBUPROFENCAPSULE;ORALCAPSULEORALIBUPROFENASCENT PHARMS INCEQ 200MG FREE ACID AND POTASSIUM SALT[]2017-12-21Dec 21, 2017NoNoNoOTCASCENT PHARMACEUTICALS INC2a0b5f2e0c32647853dface45fdf8a544f7f8d7181de73141fcb3a8313b39c87
3355A207753001IBUPROFENCAPSULE;ORALCAPSULEORALIBUPROFENAUROBINDO PHARMA LTDEQ 200MG FREE ACID AND POTASSIUM SALT[]2018-06-29Jun 29, 2018NoNoNoOTCAUROBINDO PHARMA LTD696fc743766b75d062fb2c9e5d247124e4757e336f001997556f307739fecdd4
3356A078682001IBUPROFENCAPSULE;ORALCAPSULEORALIBUPROFENBIONPHARMA INCEQ 200MG FREE ACID AND POTASSIUM SALT[]2009-03-24Mar 24, 2009NoNoNoOTCBIONPHARMA INCd240f8437152beebaf526b1d0e5493639e2962b5bf82531eb614be5ab2ca2142
3357A074782001IBUPROFENCAPSULE;ORALCAPSULEORALIBUPROFENCONTRACT PHARMACAL200MG[]1998-07-06Jul 6, 1998NoNoNoDISCNCONTRACT PHARMACAL CORPd3e9af1e9663d849949303356b08d008b070f50903d9e384ef5dc41a1b508188
3358A206568001IBUPROFENCAPSULE;ORALCAPSULEORALIBUPROFENHUMANWELL PURACAPEQ 200MG FREE ACID AND POTASSIUM SALT[]2016-06-21Jun 21, 2016NoNoNoOTCHUMANWELL PURACAP PHARMACEUTICAL WUHAN CO LTDf78c7882d2eddfbb1be89facbaf5b5a416c3b918a21a0ea0e32fe51ffdca5712
3359A079205001IBUPROFENCAPSULE;ORALCAPSULEORALIBUPROFENMARKSANS PHARMAEQ 200MG FREE ACID AND POTASSIUM SALT[]2009-06-26Jun 26, 2009NoNoNoOTCMARKSANS PHARMA LTDebe709becce5827d58a2ef6e985014e313d1bd191eeadfc66a6da5b9c0ef143e
3360A077338001IBUPROFENCAPSULE;ORALCAPSULEORALIBUPROFENP AND L DEV LLCEQ 200MG FREE ACID AND POTASSIUM SALT[]2009-07-10Jul 10, 2009NoNoNoOTCP AND L DEVELOPMENT LLC DBA PLD DEVELOPMENTS LLCb07c2054c70dba69745974a95ea7e72679abc33f4e241f8666843847fd0eba32
3361A203599001IBUPROFENCAPSULE;ORALCAPSULEORALIBUPROFENSOFGEN PHARMSEQ 200MG FREE ACID AND POTASSIUM SALT[]2016-09-07Sep 7, 2016NoNoNoOTCSOFGEN PHARMACEUTICALS LLC46019cb5c0b9fe9f17db3c58a9f29f46bc2c6fd59070dcb59bbf31563d13e120
3362A204469001IBUPROFENCAPSULE;ORALCAPSULEORALIBUPROFENSTRIDES PHARMAEQ 200MG FREE ACID AND POTASSIUM SALT[]2018-03-28Mar 28, 2018NoNoNoDISCNSTRIDES PHARMA GLOBAL PTE LTDadd9e927d0e892a9b6d6782f0414666a26129512cb0526d36514c2f65dd5616c
3363A210676001DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFENCAPSULE;ORALCAPSULEORALIBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDEAUROBINDO PHARMA LTD25MG;EQ 200MG FREE ACID AND POTASSIUM SALT[]2019-02-14Feb 14, 2019NoNoNoOTCAUROBINDO PHARMA LTD18b82f43fa2ca1811b3ec843687aad36a54c89609a3fef7476cbc4d417daff2b
3364A090397001DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFENCAPSULE;ORALCAPSULEORALIBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDEBIONPHARMA INC25MG;EQ 200MG FREE ACID AND POTASSIUM SALT[]2010-11-22Nov 22, 2010NoNoNoOTCBIONPHARMA INC877bc40f87e083009d291aab716b9ea89c3820f62ebf01a843604fb70900a2d2
3365A200888001DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFENCAPSULE;ORALCAPSULEORALIBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDESTRIDES PHARMA25MG;EQ 200MG FREE ACID AND POTASSIUM SALT[]2012-03-05Mar 5, 2012NoNoNoOTCSTRIDES PHARMA GLOBAL PTE LTD83a444beec8047d43c63e92c87058401949338af07b475ad5a9f339c33117cd8
3366A209235001IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEAUROBINDO PHARMA LTDEQ 200MG FREE ACID AND POTASSIUM SALT;30MG[]2017-12-01Dec 1, 2017NoNoNoOTCAUROBINDO PHARMA LTDc885a4555b74bf65a836b09433bcf4f1e4cb27314079aaaea0910099cf123dc3
3367A209499001ICOSAPENT ETHYLCAPSULE;ORALCAPSULEORALICOSAPENT ETHYLDR REDDYS1GMAB["AB"]2020-08-07Aug 7, 2020NoNoNoRXDR REDDYS LABORATORIES INC49b49b9f670075b9d8c093bdca393155f160b9b27b65eddc4ae114b0bfbd9be3
3368A209457001ICOSAPENT ETHYLCAPSULE;ORALCAPSULEORALICOSAPENT ETHYLHIKMA1GMAB["AB"]2020-05-21May 21, 2020NoNoNoRXHIKMA PHARMACEUTICALS USA INCcd0c8ce5e897c76af71cfd139268bea68c4a78008b67b73867afda2eedfe146b
3369A209525002ICOSAPENT ETHYLCAPSULE;ORALCAPSULEORALICOSAPENT ETHYLTEVA PHARMS USA1GM[]2020-09-11Sep 11, 2020NoNoNoDISCNTEVA PHARMACEUTICALS USAdb275f82907d7a1d1b80da1ebc917e409b74200044b6c9ebf27a63c4b60f1e6e
3370A209525001ICOSAPENT ETHYLCAPSULE;ORALCAPSULEORALICOSAPENT ETHYLTEVA PHARMS USA500MG[]2020-09-11Sep 11, 2020NoNoNoDISCNTEVA PHARMACEUTICALS USAfe8e0d4a7af4d7a952b583279e9f7b449bcc1dfc689e3381bd438ee2d09ea52e
3371A061897001ERYTHROMYCIN ESTOLATECAPSULE;ORALCAPSULEORALILOSONELILLYEQ 125MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNELI LILLY AND CO71ce4ee560ab3c52f2249a27128112ff69c86ef5d3b59dc464dcdbcf9c8436e8
3372A061897002ERYTHROMYCIN ESTOLATECAPSULE;ORALCAPSULEORALILOSONELILLYEQ 250MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNELI LILLY AND CO033d2ce81cd0288d014519a5a0875608ad54ed4c13f98a167a8346eced73d6d1
3373N205552002IBRUTINIBCAPSULE;ORALCAPSULEORALIMBRUVICAPHARMACYCLICS INC70MGAB["AB"]2017-12-20Dec 20, 2017NoYesNoRXPHARMACYCLICS INC9a10a10a5b2f2583a1d87fe9fc26bd7b6e86af2d8031bb213771cf567edcd2cf
3374N205552001IBRUTINIBCAPSULE;ORALCAPSULEORALIMBRUVICAPHARMACYCLICS INC140MGAB["AB"]2013-11-13Nov 13, 2013NoYesYesRXPHARMACYCLICS INC9363691d21dcd64d4544e02e382ecd59f20c5ba8e1c37c514daa47ac8d98e485
3375A091099001IMIPRAMINE PAMOATECAPSULE;ORALCAPSULEORALIMIPRAMINE PAMOATEHIKMAEQ 75MG HYDROCHLORIDEAB["AB"]2010-04-16Apr 16, 2010NoNoYesRXHIKMA PHARMACEUTICALS USA INCaa54157489ffc2ebf49624641106f0a092ab0c624d14b434ed935f064a437872
3376A091099002IMIPRAMINE PAMOATECAPSULE;ORALCAPSULEORALIMIPRAMINE PAMOATEHIKMAEQ 100MG HYDROCHLORIDEAB["AB"]2010-04-16Apr 16, 2010NoNoNoRXHIKMA PHARMACEUTICALS USA INCa570614c295d717092727c8f010ef22d4b158b7fba244ca32d10085674515a61
3377A091099003IMIPRAMINE PAMOATECAPSULE;ORALCAPSULEORALIMIPRAMINE PAMOATEHIKMAEQ 125MG HYDROCHLORIDEAB["AB"]2010-04-16Apr 16, 2010NoNoNoRXHIKMA PHARMACEUTICALS USA INC720c282f7a4310dae532fc0f6634fe757ad0a3a71ee2f550ac3f0172b02703e7
3378A091099004IMIPRAMINE PAMOATECAPSULE;ORALCAPSULEORALIMIPRAMINE PAMOATEHIKMAEQ 150MG HYDROCHLORIDEAB["AB"]2010-04-16Apr 16, 2010NoNoNoRXHIKMA PHARMACEUTICALS USA INC12453738f54df71ec982494ab8a2f1c8a14b723be5238c09308e4b1b43b810fc
3379A090444001IMIPRAMINE PAMOATECAPSULE;ORALCAPSULEORALIMIPRAMINE PAMOATELUPIN LTDEQ 75MG HYDROCHLORIDEAB["AB"]2010-04-16Apr 16, 2010NoNoNoRXLUPIN LTDe7bbc83990d45f5c095005bfebff59209ddd0e600f1ddf02958043ea772febcf
3380A090444002IMIPRAMINE PAMOATECAPSULE;ORALCAPSULEORALIMIPRAMINE PAMOATELUPIN LTDEQ 100MG HYDROCHLORIDEAB["AB"]2010-04-16Apr 16, 2010NoNoNoRXLUPIN LTDc8568b9cee5cbad7ae827a4e51bfa0d11cda11b4ddd7f3a7527ba5c4f829ece0
3381A090444003IMIPRAMINE PAMOATECAPSULE;ORALCAPSULEORALIMIPRAMINE PAMOATELUPIN LTDEQ 125MG HYDROCHLORIDEAB["AB"]2010-04-16Apr 16, 2010NoNoNoRXLUPIN LTD058f21b6bb934f1f9e4bcdf5e82f369a8314dbd0b4174fa8c7d94310b3008e26
3382A090444004IMIPRAMINE PAMOATECAPSULE;ORALCAPSULEORALIMIPRAMINE PAMOATELUPIN LTDEQ 150MG HYDROCHLORIDEAB["AB"]2010-04-16Apr 16, 2010NoNoNoRXLUPIN LTDb6bf3860a316740103086390f9bc1b265e686eb7850cfdefd9388bad145a51b5
3383A202338001IMIPRAMINE PAMOATECAPSULE;ORALCAPSULEORALIMIPRAMINE PAMOATEMYLAN PHARMS INCEQ 75MG HYDROCHLORIDE[]2013-06-28Jun 28, 2013NoNoNoDISCNMYLAN PHARMACEUTICALS INC44272634c537b2625a2d5652052ebe9668875da467e1f0d832b093aa6fa84280
3384A202338002IMIPRAMINE PAMOATECAPSULE;ORALCAPSULEORALIMIPRAMINE PAMOATEMYLAN PHARMS INCEQ 100MG HYDROCHLORIDE[]2013-06-28Jun 28, 2013NoNoNoDISCNMYLAN PHARMACEUTICALS INC7705012283a946e18c72f31fa9aff3bea6495eb530c858da31c26e5ab668734d
3385A202338003IMIPRAMINE PAMOATECAPSULE;ORALCAPSULEORALIMIPRAMINE PAMOATEMYLAN PHARMS INCEQ 125MG HYDROCHLORIDE[]2013-06-28Jun 28, 2013NoNoNoDISCNMYLAN PHARMACEUTICALS INCdbd0b51314ef5f7b5c8314d7c66afa83fdc50e516c531011ac1e24fae29196d3
3386A202338004IMIPRAMINE PAMOATECAPSULE;ORALCAPSULEORALIMIPRAMINE PAMOATEMYLAN PHARMS INCEQ 150MG HYDROCHLORIDE[]2013-06-28Jun 28, 2013NoNoNoDISCNMYLAN PHARMACEUTICALS INC8ef4e1a7261a3cbcac4a607e066ac2d9bf9a1d8bfed4f5377edb50a8f417f864
3387N017690001LOPERAMIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALIMODIUMJ AND J CONSUMER INC2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesNoNoDISCNJOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV9139b88b9a7ea61fc823667a17774664ed33981db2382b3e45fb4df3008d32f0
3388N017694001LOPERAMIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALIMODIUMJ AND J CONSUMER INC2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNJOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV85bdeec921e4bedea84c9a408f28406c6999e3831fc41671efc1f406892f9dd2
3389N204684001MILTEFOSINECAPSULE;ORALCAPSULEORALIMPAVIDOKNIGHT THERAPS50MG[]2014-03-19Mar 19, 2014NoYesYesRXKNIGHT THERAPEUTICS USA INCdd242c6991f78986f80b32d7709f5d235a5078b9216e75f6c25c547b79523e28
3390A070266001INDOMETHACINCAPSULE;ORALCAPSULEORALINDO-LEMMONTEVA25MG[]1985-11-07Nov 7, 1985NoNoNoDISCNTEVA PHARMACEUTICALS USA INC997af874ae57896721183bf07640a0c71bfb21406241067b29c12cc1ff0ef44a
3391A070267001INDOMETHACINCAPSULE;ORALCAPSULEORALINDO-LEMMONTEVA50MG[]1985-11-07Nov 7, 1985NoNoNoDISCNTEVA PHARMACEUTICALS USA INC21db633885b616d7b660f89dc9df12287aef80387b84410122b424e89a020141
3392N016059001INDOMETHACINCAPSULE;ORALCAPSULEORALINDOCINEGALET25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNEGALET US INC46f35106742a7f83ced4c121a907ad49af1d61c39c33e52d37bef37b148d30ff
3393N016059002INDOMETHACINCAPSULE;ORALCAPSULEORALINDOCINEGALET50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNEGALET US INCca5e88c2213a4388bb8d2742c776ccd79b95cd0dc64d4ec8073116b27266ffe0
3394A076666001INDOMETHACINCAPSULE;ORALCAPSULEORALINDOMETHACINABLE25MG[]2003-12-17Dec 17, 2003NoNoNoDISCNABLE LABORATORIES INCa1c6a478ffb57d836329463e2dfc509943df02fcc0fc3a9a8ef1d47953f16026
3395A076666002INDOMETHACINCAPSULE;ORALCAPSULEORALINDOMETHACINABLE50MG[]2003-12-17Dec 17, 2003NoNoNoDISCNABLE LABORATORIES INC13cfad17055214d6c4eba8025028fab7892f40209650991b7a720409ca0c57b5
3396A071148001INDOMETHACINCAPSULE;ORALCAPSULEORALINDOMETHACINANI PHARMS INC25MG[]1987-03-18Mar 18, 1987NoNoNoDISCNANI PHARMACEUTICALS INC3c072fd2d3727feba540d779a2a88fdc055957b08c01e5b50357ed4613764583
3397A071149001INDOMETHACINCAPSULE;ORALCAPSULEORALINDOMETHACINANI PHARMS INC50MG[]1987-03-18Mar 18, 1987NoNoNoDISCNANI PHARMACEUTICALS INCa02abc0eca1a997eecee56979dbdf3374bf3365cac77d375143d97f7b6c7c34f
3398A090403001INDOMETHACINCAPSULE;ORALCAPSULEORALINDOMETHACINCADILA25MGAB["AB"]2010-11-15Nov 15, 2010NoNoNoRXCADILA HEALTHCARE LTD4658e7796d15cbd0c9d2db7dceb244d3c08456f95cb48294c682750feaaf3175
3399A090403002INDOMETHACINCAPSULE;ORALCAPSULEORALINDOMETHACINCADILA50MGAB["AB"]2010-11-15Nov 15, 2010NoNoNoRXCADILA HEALTHCARE LTDe7bbcfc58aa734734110e4104460cb1a2c41dd72a08c9cef7f0941cd1d36a691
3400N018829002INDOMETHACINCAPSULE;ORALCAPSULEORALINDOMETHACINCHARTWELL MOLECULES25MG[]1984-08-06Aug 6, 1984NoNoNoDISCNCHARTWELL MOLECULES LLC18ebf9718ac684aec6f3dfb18ec0aa528009a510356b2bc21468712051dd0451
3401A070651001INDOMETHACINCAPSULE;ORALCAPSULEORALINDOMETHACINCHARTWELL MOLECULES50MG[]1986-03-05Mar 5, 1986NoNoNoDISCNCHARTWELL MOLECULES LLCd35906a999b40d222fcf11626b23710bd15a38d84d1295e61d8b5bb60d9da20d