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← Snapshot 21

Orange Book snapshot 21: Products

Products page 33 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
1602A077179002AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDETEVA PHARMSEQ 5MG BASE;10MG[]2007-05-18May 18, 2007NoNoNoDISCNTEVA PHARMACEUTICALS USA2edc977563484b9e82b46abb3bb95b53117b90b79aab3021460bf52aab9954ef
1603A077179003AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDETEVA PHARMSEQ 5MG BASE;20MG[]2007-05-18May 18, 2007NoNoNoDISCNTEVA PHARMACEUTICALS USA2cd13dab052231b43c0209ca7873ca02f01afd86e66a7b02623a1faa6e1b8e45
1604A077179005AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDETEVA PHARMSEQ 5MG BASE;40MG[]2011-07-05Jul 5, 2011NoNoNoDISCNTEVA PHARMACEUTICALS USA2359d71dcde3aff625db8e9647ed146b0277096a755f0d4c64d356a2c6a3a116
1605A077179004AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDETEVA PHARMSEQ 10MG BASE;20MG[]2007-05-18May 18, 2007NoNoNoDISCNTEVA PHARMACEUTICALS USAa57ae1c21f0ad7352d058a105ee486067832c5a674c3f76c3fc9de411ee20d35
1606A077179006AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDETEVA PHARMSEQ 10MG BASE;40MG[]2011-07-05Jul 5, 2011NoNoNoDISCNTEVA PHARMACEUTICALS USA73e1bc8e8a89383fcafeab63a8c11b0a29b8488d9ebb77c532fe457c09d18e4d
1607A077890001AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEWATSON LABSEQ 2.5MG BASE;10MGAB["AB"]2010-10-14Oct 14, 2010NoNoNoRXWATSON LABORATORIES INCb34ff557262c2e2077978b84bf4fe6ab6d2f105b1510dab3c84c8de6bb911adf
1608A077890002AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEWATSON LABSEQ 5MG BASE;10MGAB["AB"]2010-10-14Oct 14, 2010NoNoNoRXWATSON LABORATORIES INC05c96551936f1ccc61359982ce4f6372c557ad8ec5b2370c7a92afb9fbfb639b
1609A077890003AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEWATSON LABSEQ 5MG BASE;20MGAB["AB"]2010-10-14Oct 14, 2010NoNoNoRXWATSON LABORATORIES INCcb170d796bcd583606355da95e3950580372b1e84945d022d9ea7a36adbf3590
1610A077890004AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEWATSON LABSEQ 10MG BASE;20MGAB["AB"]2010-10-14Oct 14, 2010NoNoNoRXWATSON LABORATORIES INCda308ee7b53f1367a46469f6f7e0bd83128eca12878a69866de863a0ce9302bf
1611A090364001AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEWATSON LABS INCEQ 5MG BASE;40MGAB["AB"]2011-07-05Jul 5, 2011NoNoNoRXWATSON LABORATORIES INC177cbb5e61e8db589f77e4831037bbaae20959fd9ec2df14adc4d1361700b5fb
1612A090364002AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEWATSON LABS INCEQ 10MG BASE;40MGAB["AB"]2011-07-05Jul 5, 2011NoNoNoRXWATSON LABORATORIES INC9fb9efddb766701b4b3c63ef5c9cee4421839cfd325c9b5ab81e4a62e4bd4cb0
1613A075945001ISOTRETINOINCAPSULE;ORALCAPSULEORALAMNESTEEMMYLAN PHARMS INC10MGAB1["AB1"]2002-11-08Nov 8, 2002NoNoNoRXMYLAN PHARMACEUTICALS INC608ad420dd3fe5bf6cb919ca300ca6b71f4b2b258ddc3c98c03de7111dd4e184
1614A075945002ISOTRETINOINCAPSULE;ORALCAPSULEORALAMNESTEEMMYLAN PHARMS INC20MGAB1["AB1"]2002-11-08Nov 8, 2002NoNoNoRXMYLAN PHARMACEUTICALS INCb8bcc1eacf00325922f2f3dac1919e2c3a9b4aa10aa055d4e325ecdcc368b9bb
1615A075945003ISOTRETINOINCAPSULE;ORALCAPSULEORALAMNESTEEMMYLAN PHARMS INC40MGAB1["AB1"]2002-11-08Nov 8, 2002NoNoNoRXMYLAN PHARMACEUTICALS INC8a9d039869f81fd3401611ea76b1849b31de9dc5f542a80e726fca1301aff61c
1616A065271001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINAUROBINDO250MGAB["AB"]2005-11-09Nov 9, 2005NoNoNoRXAUROBINDO PHARMA LTDe15a8f355a2e4d24a7c3fdc8c85493237d425fd1777592cc8a3f0efa89d34326
1617A065271002AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINAUROBINDO500MGAB["AB"]2005-11-09Nov 9, 2005NoNoNoRXAUROBINDO PHARMA LTD4f34afbd8dc77fe1f82c0e17a8eaec2e4d9387bcfc224094403c162b1cc912d1
1618A062058001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINBELCHER PHARMS250MGAB["AB"]Approved Prior to Jan 1, 1982YesNoNoRXBELCHER PHARMACEUTICALS INCa6ba8db711687f1b0c2c91079d8fc1883975ba0a61ae67738b0412dbbe3629b1
1619A062058002AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINBELCHER PHARMS500MGAB["AB"]Approved Prior to Jan 1, 1982YesNoNoRXBELCHER PHARMACEUTICALS INC7b3727f94af7ef1839ff814219c3ec612703f361f824dfac40a30ae6308ed1f9
1620A062884001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINDAVA PHARMS INC250MG[]1988-02-25Feb 25, 1988NoNoNoDISCNDAVA PHARMACEUTICALS INC6710fb034d2107ce45c9a087f583cc80e2cce0ee5d9e96ba373b1926cbeb1c29
1621A062881001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINDAVA PHARMS INC500MG[]1988-02-25Feb 25, 1988NoNoNoDISCNDAVA PHARMACEUTICALS INC385e08718578136ae5277da36c97452acccf6e8ee52f7d3e84394d63f9d0edfb
1622A065291001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINHIKMA PHARMS250MGAB["AB"]2007-02-05Feb 5, 2007NoNoNoRXHIKMA PHARMACEUTICALSc892b90a22636808e76a046932d5e10d0fa394feebf7176fee4d86fb190e2abc
1623A065291002AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINHIKMA PHARMS500MGAB["AB"]2007-02-05Feb 5, 2007NoNoNoRXHIKMA PHARMACEUTICALS34c1402f19236d8576805bc2e48a416435355dec7889805730c4f06b28fb80be
1624A062528001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINLABS ATRAL250MG[]1985-08-07Aug 7, 1985NoNoNoDISCNLABORATORIOS ATRAL SARL42ae421025194adbff82228cfbce8643e7508d9472721d668a503a6cd227aaff
1625A062528002AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINLABS ATRAL500MG[]1985-08-07Aug 7, 1985NoNoNoDISCNLABORATORIOS ATRAL SARLbb4a7f613958513e89c6b222ab2d3b42e27fc2a3609bf7247377f0af7e59c919
1626A062067001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINMYLAN250MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNMYLAN PHARMACEUTICALS INC376f4b667c1c4836c669a1e346dc0b55e13780a5e9752baafd3952a17900606a
1627A062067002AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINMYLAN500MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNMYLAN PHARMACEUTICALS INC31b6c9bede9ddba43a1c950092ccd5ef540276c4ea8d474da111be2ad9125a3f
1628A064076001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINSANDOZ250MGAB["AB"]1994-09-30Sep 30, 1994NoNoNoRXSANDOZ INC9e53fb1fa75f821abbccb73dd30f840e2766f174c1e817994a0190a77ea32ff5
1629A064076002AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINSANDOZ500MGAB["AB"]1994-09-30Sep 30, 1994NoNoNoRXSANDOZ INCb5a35fcdff76ab55dcacde4335099a5fe2a159336adc393d58e22b2a089765f7
1630A065016001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINSUN PHARM INDS LTD250MG[]1999-04-08Apr 8, 1999NoNoNoDISCNSUN PHARMACEUTICAL INDUSTRIES LTDa76de6241dd45523bc891f5389f56b00bfe8f0df8ae07ee06c2bd6785dca2f68
1631A065016002AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINSUN PHARM INDS LTD500MG[]1999-04-08Apr 8, 1999NoNoNoDISCNSUN PHARMACEUTICAL INDUSTRIES LTD9ecd49adb4ec7428e62063f7b4049c24638c5dfe2dc37adc6ba59dbbd66b5043
1632A061926001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINTEVA250MGAB["AB"]Approved Prior to Jan 1, 1982YesNoNoRXTEVA PHARMACEUTICALS USA INC6696c0ee82bed4cd703650465fb371ba0bbb2b71dc6398971b0639ae1442fbc4
1633A062853001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINTEVA250MG[]1987-12-22Dec 22, 1987NoNoNoDISCNTEVA PHARMACEUTICALS USA INC34f102e1ce668121ab81e770c38d07b20fc09107fc92d17c53225043ba939a6c
1634A063030001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINTEVA250MG[]1989-02-28Feb 28, 1989NoNoNoDISCNTEVA PHARMACEUTICALS USA INC1fababc802f966d267eed91c63bfdffead64e86959a1e02a1df181e403fb237e
1635A061926003AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINTEVA500MGAB["AB"]Approved Prior to Jan 1, 1982YesNoYesRXTEVA PHARMACEUTICALS USA INCc591431707364083cdf815682f3d8211bb717751f8d77af888492847744b8872
1636A062854001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINTEVA500MG[]1987-12-22Dec 22, 1987NoNoNoDISCNTEVA PHARMACEUTICALS USA INC2cb888b599215a4754e9409ae60c87977874fed0d1003882169c10a2ef80c8c3
1637A063031001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXICILLINTEVA500MG[]1989-02-28Feb 28, 1989NoNoNoDISCNTEVA PHARMACEUTICALS USA INC7e7ddcea2a82c873755e5b954d3ab88482129aa1c02c0bf0592c1ac616f45aba
1638N050459001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXILGLAXOSMITHKLINE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNGLAXOSMITHKLINE320da51b417b00db8a221f2387aa44d2f0547062246e919b4392787d7f41f3e5
1639N050459002AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXILGLAXOSMITHKLINE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNGLAXOSMITHKLINE0a7e7be9899d1546d8041e4d9d40b12b1d5e2c5fb35df1413c66f496673b076b
1640A062216001AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXILNEOPHARMA250MGAB["AB"]Approved Prior to Jan 1, 1982YesNoNoRXNEOPHARMA INC81961b56a0f9fef90be89e69ed6503ab4d20d57563dfe3211bb31d38aaae0871
1641A062216004AMOXICILLINCAPSULE;ORALCAPSULEORALAMOXILNEOPHARMA500MGAB["AB"]Approved Prior to Jan 1, 1982YesNoNoRXNEOPHARMA INC25a50313f012a52b42f1b1a11b1ff0e6c05137159f08a12e7d3ec34d0ac6a6a9
1642A061602001AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATEBELCHER PHARMSEQ 250MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNBELCHER PHARMACEUTICALS INC687937b9b3d3f9e24da6f38679f9b02d8d43b51b0024c130005bcf0f49abf1fa
1643A061602002AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATEBELCHER PHARMSEQ 500MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNBELCHER PHARMACEUTICALS INCd67110ebacbdeeec9ba2b72509fce5155fc4913dfff43ba3659d21c8c4cd0f54
1644A062883001AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATEDAVA PHARMS INCEQ 250MG BASE[]1988-02-25Feb 25, 1988NoNoNoDISCNDAVA PHARMACEUTICALS INC6bf81222b5215c4e3f3ed9066649fb06f372f24060bf23469df16758bb561527
1645A062882001AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATEDAVA PHARMS INCEQ 500MG BASE[]1988-02-25Feb 25, 1988NoNoNoDISCNDAVA PHARMACEUTICALS INC910f4fb8fe43c7f1dfa1810e66d176975bf39c1b31f246cfe231b9c18d194c7a
1646A061502001AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATEHERITAGE PHARMAEQ 250MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNHERITAGE PHARMA LABS INC6077ded1a81d8c3018ab6184dcc69fca7320b2d0724435f19e814b5b1659d502
1647A061502002AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATEHERITAGE PHARMAEQ 500MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNHERITAGE PHARMA LABS INC2f9ca12c1f4533a20347a85732c2507c00d48c0bb33f880396cb83cbf405237e
1648A060765001AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATEIVAX SUB TEVA PHARMSEQ 250MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA5b472a7bf28dbcc41de452e929bb76538da106cf7af9ec2692a79e73898e971b
1649A060765002AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATEIVAX SUB TEVA PHARMSEQ 500MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAf503617e00e9b4cd504d8c10b3cc6bd4476ca213ab551324edbcca240a1ec384
1650A062208001AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATELEDERLEEQ 250MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNLEDERLE LABORATORIES DIV AMERICAN CYANAMID CO08fec6584a0a3ab1f5f1362469da45cd3df662b4bd9b835c78c1d6847ce63149
1651A062208002AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATELEDERLEEQ 500MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNLEDERLE LABORATORIES DIV AMERICAN CYANAMID CO414dd6fe05398eb529242af5f02bff8eb55bd4eb4d6b6ddd0fa924a0c9e7541f