← Snapshot 21

Orange Book snapshot 21: Products

Products page 75 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
3702A074865002MEXILETINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMEXILETINE HYDROCHLORIDEWATSON LABS200MG[]1998-04-13Apr 13, 1998NoNoNoDISCNWATSON LABORATORIES INCa66d61265a98495a275e52a8fb060f69f89a1b8c416dad657ffe89d4875c60f1
3703A074711003MEXILETINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMEXILETINE HYDROCHLORIDEWATSON LABS250MG[]1997-02-26Feb 26, 1997NoNoNoDISCNWATSON LABORATORIES INC122a85777469a99bc18d7b75d71be280cab8004ff29a5159823b0a8643744689
3704A074865003MEXILETINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMEXILETINE HYDROCHLORIDEWATSON LABS250MG[]1998-04-13Apr 13, 1998NoNoNoDISCNWATSON LABORATORIES INC21e1797b562fb6a64191bbc1d78284216d72b617a3cb65f769267f3ae890affb
3705N018873002MEXILETINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMEXITILBOEHRINGER INGELHEIM150MG[]1985-12-30Dec 30, 1985NoYesNoDISCNBOEHRINGER INGELHEIM64b50d1931a04be5aeb958c678ad5f64e23265902e57a942679b39274d599035
3706N018873003MEXILETINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMEXITILBOEHRINGER INGELHEIM200MG[]1985-12-30Dec 30, 1985NoYesNoDISCNBOEHRINGER INGELHEIM6ac8f63a19d7208e42a3b2065e2ab47f809410dfe0610933ccd5a3c4e717fa1c
3707N018873004MEXILETINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMEXITILBOEHRINGER INGELHEIM250MG[]1985-12-30Dec 30, 1985NoYesNoDISCNBOEHRINGER INGELHEIM8e03b4e56a7d42e055e02aea13ea311359bb2e0c2da7f4b607b9644257136092
3708N020504001HYDROCHLOROTHIAZIDECAPSULE;ORALCAPSULEORALMICROZIDETEVA BRANDED PHARM12.5MGAB["AB"]1996-12-27Dec 27, 1996NoYesYesRXTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INCfaddabad7c670f2dff7e3541e2ef19c47d9c04d40aa3525469fce1325a794f9b
3709A070626001IBUPROFENCAPSULE;ORALCAPSULEORALMIDOLBAYER200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1987-09-02Sep 2, 1987NoNoNoDISCNBAYER HEALTHCARE LLCdb32ab811a4ea71b36f99b3b40945c3b28635eb55a2ddb31d913f9840aa1f0f1
3710A071002001IBUPROFENCAPSULE;ORALCAPSULEORALMIDOLBAYER200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1987-09-02Sep 2, 1987NoNoNoDISCNBAYER HEALTHCARE LLC7066434c02a0167549d67ea9e1b14e3175f65143ce52d803f3a52f6a5cb3c772
3711N021472001IBUPROFENCAPSULE;ORALCAPSULEORALMIDOL LIQUID GELSBIONPHARMA INC200MG[]2002-10-18Oct 18, 2002NoYesYesOTCBIONPHARMA INCc8769008ef9d4c18ee114fe642133383c29c9ccfec199306023a7af5e0a703a3
3712A208342001MIGLUSTATCAPSULE;ORALCAPSULEORALMIGLUSTATANI PHARMS INC100MGAB["AB"]2018-04-17Apr 17, 2018NoNoNoRXANI PHARMACEUTICALS INC79cf24a90dd04f72798d1817e1281c48e63c35ca57b703907883365d9bb3222d
3713A209821001MIGLUSTATCAPSULE;ORALCAPSULEORALMIGLUSTATEDENBRIDGE PHARMS100MGAB["AB"]2020-08-06Aug 6, 2020NoNoNoRXEDENBRIDGE PHARMACEUTICALS LLC47616e446f6ac7851e8ef24ee0cbf056321898951032304a42375cb44b7da999
3714N008855004PHENSUXIMIDECAPSULE;ORALCAPSULEORALMILONTINPARKE DAVIS500MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNPARKE DAVIS DIV WARNER LAMBERT COb49eff773f48be86889033dffb3e31cd5a181d88035a06d984c768014f5bc981
3715N017442002PRAZOSIN HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINIPRESSPFIZEREQ 1MG BASEAB["AB"]Approved Prior to Jan 1, 1982YesYesNoRXPFIZER LABORATORIES DIV PFIZER INC3aecaf5d66bdd2be57f8bae43ae68abf2e97e4b445b224370f08dabeb94d52eb
3716N017442003PRAZOSIN HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINIPRESSPFIZEREQ 2MG BASEAB["AB"]Approved Prior to Jan 1, 1982YesYesYesRXPFIZER LABORATORIES DIV PFIZER INCbbb11b61730dc100898a64b4a7dd55ffaa82f546221b0611fb4a10ddacc1be2d
3717N017442001PRAZOSIN HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINIPRESSPFIZEREQ 5MG BASEAB["AB"]Approved Prior to Jan 1, 1982YesYesNoRXPFIZER LABORATORIES DIV PFIZER INC921eed54d62e5ef32c7ecee0e96b0ab763161c0953070cc028e3ca6135b8b9af
3718N017986001POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINIZIDEPFIZER0.5MG;EQ 1MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNPFIZER INC1ea2d427d948db7421c17da3ba10c330d1f4d031d38e349b233504f67e4d6d91
3719N017986002POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINIZIDEPFIZER0.5MG;EQ 2MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNPFIZER INCcd6922d35145fbf0177412ccbe48b54bb25dbe697713b71f94e8ceeebc7e266f
3720N017986003POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINIZIDEPFIZER0.5MG;EQ 5MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNPFIZER INCee418ce128a7028cef943ca4757303c6285f92b81e1e755475e42ba82d8872bf
3721N050649001MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCINBAUSCHEQ 50MG BASEAB["AB"]1990-05-31May 31, 1990NoYesNoRXBAUSCH HEALTH US LLC1a55a5c48f16e87799f8c36dd6902bd021755a5cc4c8285fb31bcac962b2bb57
3722N050649003MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCINBAUSCHEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]2001-02-12Feb 12, 2001NoYesNoDISCNBAUSCH HEALTH US LLC88e2f6c9c3e6c0312d57a96e9886dfd9586e5655adb00ed268c65e7d6a4c2bf2
3723N050649002MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCINBAUSCHEQ 100MG BASEAB["AB"]1990-05-31May 31, 1990NoYesNoRXBAUSCH HEALTH US LLCd1e10f1fbf7d2b81173749d15eb62243a8eb18f49203ce98f3c30cf31b5ffc04
3724N050315002MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCINTRIAX PHARMSEQ 50MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNTRIAX PHARMACEUTICALS LLCd3b9ee99eb7d92ad02942b3bbb02ebd34856fdfdf82db879f3f340a0102b85ba
3725N050315001MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCINTRIAX PHARMSEQ 100MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNTRIAX PHARMACEUTICALS LLC76f5700c133d2afad102f11f3bb6decaea2fb763ba863389dd1f163c54a87fa7
3726A065470001MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDEAUROBINDO PHARMAEQ 50MG BASEAB["AB"]2008-03-11Mar 11, 2008NoNoNoRXAUROBINDO PHARMA LTDdd679c8a3355c796eda022d1d6cd945d0b70e1cb8a66fc2f8e43ba2cdb52f91e
3727A065470002MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDEAUROBINDO PHARMAEQ 75MG BASEAB["AB"]2008-03-11Mar 11, 2008NoNoNoRXAUROBINDO PHARMA LTD927fb3e680cb4a29022eb41ac501cc44acd54a30cb90ba7728c71f2ceec797ee
3728A065470003MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDEAUROBINDO PHARMAEQ 100MG BASEAB["AB"]2008-03-11Mar 11, 2008NoNoNoRXAUROBINDO PHARMA LTD809799535032935f01dd3bb9cd05208dd2973db79fd9be5003f8c7edaac22932
3729A065005001MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDEIMPAX LABSEQ 50MG BASEAB["AB"]1999-03-23Mar 23, 1999NoNoNoRXIMPAX LABORATORIES INC909f2d2c076346b981e79d6eb32ad29e5e018830ca29d3a6ec4f904c3a239bbc
3730A065005003MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDEIMPAX LABSEQ 75MG BASEAB["AB"]2001-04-18Apr 18, 2001NoNoNoRXIMPAX LABORATORIES INC15b02bd9678ff2cb33b97622fe1d34eb95f20d396c8d87ba34165068e0ff40eb
3731A065005002MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDEIMPAX LABSEQ 100MG BASEAB["AB"]1999-03-23Mar 23, 1999NoNoNoRXIMPAX LABORATORIES INC92d78b6aab7edb4bb5b88a8caff424ca5ce37a111902197b03fc5faaef72736a
3732A090867001MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDESUN PHARM INDS INCEQ 50MG BASEAB["AB"]2013-05-13May 13, 2013NoNoNoRXSUN PHARMACEUTICAL INDUSTRIES INC0e28480dd1efed0102d45238c0c24505c0ecce5ffc7ae534ba9aa9b48b2a4dd1
3733A090867002MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDESUN PHARM INDS INCEQ 75MG BASEAB["AB"]2013-05-13May 13, 2013NoNoNoRXSUN PHARMACEUTICAL INDUSTRIES INCbdefffe8bf1fb0709069246d41426eee8a32b03acb5b139d277034eedf17b833
3734A090867003MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDESUN PHARM INDS INCEQ 100MG BASEAB["AB"]2013-05-13May 13, 2013NoNoNoRXSUN PHARMACEUTICAL INDUSTRIES INC939f92a8b2ae2b5ba360cc9168560cc5853cb802a3511e3b1142ab28b848a4d5
3735A065062001MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDETORRENTEQ 50MG BASEAB["AB"]2000-11-30Nov 30, 2000NoNoNoRXTORRENT PHARMA INC7e633fea34c48d7f526bdc282e895d5dbfe8834500c02fdacd662735a3e400b5
3736A065062002MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDETORRENTEQ 75MG BASEAB["AB"]2000-11-30Nov 30, 2000NoNoNoRXTORRENT PHARMA INC7497e3c98958ce617f5dd54b046887bc2db7f53bf7d31201bb2428545a694c06
3737A065062003MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDETORRENTEQ 100MG BASEAB["AB"]2000-11-30Nov 30, 2000NoNoNoRXTORRENT PHARMA INC883ea424a34335bbb3747c99443d3c2129f554d5bf71729dd7abe7c09c28781e
3738A063065002MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDEWATSON LABSEQ 75MG BASEAB["AB"]1999-06-10Jun 10, 1999NoNoNoRXWATSON LABORATORIES INC0eee66e58d32efe77f9fbb81f13d7b32d77ead0b43345abb42db627a7f399205
3739A063065001MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDEWATSON LABSEQ 100MG BASEAB["AB"]1991-12-30Dec 30, 1991NoNoNoRXWATSON LABORATORIES INC08aa41dd6f33b599107c6967e712a4f1473d89370dac42351365ea9f1fde28fb
3740A063181001MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDEWATSON LABS TEVAEQ 50MG BASEAB["AB"]1991-12-30Dec 30, 1991NoNoNoRXWATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INCaa64f3a6daac5b4e3279039bf36f07b96ef8ad353d0206897a44fcfee20c2fba
3741A063011001MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDEZYDUSEQ 50MG BASEAB["AB"]1992-03-02Mar 2, 1992NoNoNoRXZYDUS WORLDWIDE DMCC80a38641ff3a09e67ed25ae5e64a43bf638a98d2722c115bc0457761af716a3d
3742A063009002MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDEZYDUSEQ 75MG BASEAB["AB"]2003-08-12Aug 12, 2003NoNoNoRXZYDUS WORLDWIDE DMCC565219260111cea649045beb24138b1f4b1b89826b90f3dee145e9630c5b41cc
3743A063009001MINOCYCLINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMINOCYCLINE HYDROCHLORIDEZYDUSEQ 100MG BASEAB["AB"]1992-03-02Mar 2, 1992NoNoYesRXZYDUS WORLDWIDE DMCC8ea53626b2ad4814e9d157781a360d250bdf2cd57e9abccc3cdaa74f52d061f6
3744N204820001COLCHICINECAPSULE;ORALCAPSULEORALMITIGAREHIKMA INTL PHARMS0.6MG[]2014-09-26Sep 26, 2014NoYesYesRXHIKMA INTERNATIONAL PHARMACEUTICALS LLCaddee0c968b5f18a61e06c52292ef9087f042919c47c6f79923a424a20edcb7c
3745N017111001MOLINDONE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMOBANENDO PHARMS5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNENDO PHARMACEUTICALS INC898b58a1e85f06fd13003fa86c065e91377978e191a5f70a2293e13aee5623e7
3746N017111002MOLINDONE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMOBANENDO PHARMS10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNENDO PHARMACEUTICALS INC02fff9662db4cce784a4dc6bd62831297eca4c484e4467a0278e55e895155b95
3747N017111003MOLINDONE HYDROCHLORIDECAPSULE;ORALCAPSULEORALMOBANENDO PHARMS25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNENDO PHARMACEUTICALS INC318445872a37bece79e4fa04ba20e475d02a83402bc80f76656cc626b15f48d8
3748N018719002TRILOSTANECAPSULE;ORALCAPSULEORALMODRASTANEBIOENVISION30MG[]1984-12-31Dec 31, 1984NoNoNoDISCNBIOENVISION INC0953acd04cf8d834e27bbef9f22afe097588b734c02804ed46e44c8746b38fa8
3749N018719001TRILOSTANECAPSULE;ORALCAPSULEORALMODRASTANEBIOENVISION60MG[]1984-12-31Dec 31, 1984NoNoNoDISCNBIOENVISION INCc4628770d83027076d6ce7255ad452e197ce26e39c973a1554eb770567402f62
3750N050641002DOXYCYCLINECAPSULE;ORALCAPSULEORALMONODOXCHARTWELL RXEQ 50MG BASE[]1992-02-10Feb 10, 1992NoYesNoDISCNCHARTWELL RX SCIENCES LLCb1e9f4331d6a864848e6012ade3f1a97f09e8d3c5cdb4c89da39fdbfd6f704c9
3751N050641003DOXYCYCLINECAPSULE;ORALCAPSULEORALMONODOXCHARTWELL RXEQ 75MG BASE[]2006-10-18Oct 18, 2006NoYesNoDISCNCHARTWELL RX SCIENCES LLC3eca561ddfc1288cdaa367df8437623ee9f8c2d1c5adf88d0ea8f179d230d996