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Orange Book snapshot 21: Products

Products page 32 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
1552A070589001AMANTADINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMANTADINE HYDROCHLORIDEUPSHER SMITH LABS100MGAB["AB"]1986-08-05Aug 5, 1986NoNoNoRXUPSHER SMITH LABORATORIES LLC5edba4039d18a378ed494acd40ad865d4ba29f9c2c67628e5ea3eb370e998177
1553A071382001AMANTADINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMANTADINE HYDROCHLORIDEWATSON LABS100MG[]1987-01-21Jan 21, 1987NoNoNoDISCNWATSON LABORATORIES INCbe07ec7e4a6b07d5b6481d15b78712fc0f79f4f25a4c75333ffc013413896ca3
1554A208107001AMANTADINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMANTADINE HYDROCHLORIDEWATSON LABS INC100MGAB["AB"]2016-12-06Dec 6, 2016NoNoNoRXWATSON LABORATORIES INC358fa4c63c2289a8f769b35f435bdcb183e4d62bcaba26b0c1f03e0b089190f2
1555A208278001AMANTADINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMANTADINE HYDROCHLORIDEZYDUS PHARMS100MGAB["AB"]2016-05-31May 31, 2016NoNoNoRXZYDUS PHARMACEUTICALS USA INCeb16171935c1b061767d39ab0e1ba8f5a4152971527ad13d350cea268f48e95b
1556N007984001BROMODIPHENHYDRAMINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMBODRYLPARKE DAVIS25MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNPARKE DAVIS DIV WARNER LAMBERT CO217298facd9efe57995e4460d694b41cb639b8c79597c63df8c0765e3ab48891
1557A062041001AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMCILLPARKE DAVISEQ 250MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNPARKE DAVIS DIV WARNER LAMBERT COecad8ffe34b5be4b8710bbc86cc0baa20db2d6f81046bcc83fd1c4aead954417
1558A062041002AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMCILLPARKE DAVISEQ 500MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNPARKE DAVIS DIV WARNER LAMBERT CO5eb211a87b7aa1a38e59ecc878d0e2d6ef22a6aa8fe05e4fdbc3f73a5cf418f3
1559N021908002LUBIPROSTONECAPSULE;ORALCAPSULEORALAMITIZASUCAMPO PHARMA LLC8MCG[]2008-04-29Apr 29, 2008NoYesNoRXSUCAMPO PHARMA AMERICAS LLCaada3fa03d75ac0c9c7d662ab96bf0a491053b700f33d0f229ed61e2830d2d12
1560N021908001LUBIPROSTONECAPSULE;ORALCAPSULEORALAMITIZASUCAMPO PHARMA LLC24MCG[]2006-01-31Jan 31, 2006NoYesYesRXSUCAMPO PHARMA AMERICAS LLCfaba08811d9e9afcfa199780452ca8679d018a3133fc1a97f6105236d67d5aec
1561A091431001AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAPOTEXEQ 2.5MG BASE;10MGAB["AB"]2013-12-30Dec 30, 2013NoNoNoRXAPOTEX INC4e726a814a50f2a48ebcc017a72788d15870a626aec259c03a6355f433dd93a3
1562A091431002AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAPOTEXEQ 5MG BASE;10MGAB["AB"]2013-12-30Dec 30, 2013NoNoNoRXAPOTEX INC20e155934e33f3f6c4f10089ed2fa902606c4143580d4c290498a45daf09ba3d
1563A091431003AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAPOTEXEQ 5MG BASE;20MGAB["AB"]2013-12-30Dec 30, 2013NoNoNoRXAPOTEX INC104891761a5d8eaa009bb98c0d153720d4a3e0be5a30b2e22a4fe2a934b49c47
1564A091431004AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAPOTEXEQ 5MG BASE;40MGAB["AB"]2013-12-30Dec 30, 2013NoNoNoRXAPOTEX INCb704f160d9a0763a63c2e010bfe584c083ded45a7fbff0c417dbf80f57071db1
1565A091431005AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAPOTEXEQ 10MG BASE;20MGAB["AB"]2013-12-30Dec 30, 2013NoNoNoRXAPOTEX INCe49d9113237ac95f20fb5b3509be2466f927fb3eaf83ae17294b944d1dc1c7e9
1566A091431006AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAPOTEXEQ 10MG BASE;40MGAB["AB"]2013-12-30Dec 30, 2013NoNoNoRXAPOTEX INC89318d2767e85d9d7f6d0cdb2233bd83ba4a8f8a63914993bc42a3f9fb4e581b
1567A202239001AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAUROBINDO PHARMA LTDEQ 2.5MG BASE;10MGAB["AB"]2012-09-05Sep 5, 2012NoNoNoRXAUROBINDO PHARMA LTDa5c5e0750aa06e5898d6222bd16378b4ca820b5bcde3050b44cd2e0bed17a92c
1568A202239002AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAUROBINDO PHARMA LTDEQ 5MG BASE;10MGAB["AB"]2012-09-05Sep 5, 2012NoNoNoRXAUROBINDO PHARMA LTD9f215a3f6ed90427fe9718495435289b411676385a4edc7fd174abe514743d29
1569A202239003AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAUROBINDO PHARMA LTDEQ 5MG BASE;20MGAB["AB"]2012-09-05Sep 5, 2012NoNoNoRXAUROBINDO PHARMA LTDc7649e066d24b5f092707935cda9924c37a2001fe6026ae7687fd2adaa3675db
1570A202239004AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAUROBINDO PHARMA LTDEQ 5MG BASE;40MGAB["AB"]2012-09-05Sep 5, 2012NoNoNoRXAUROBINDO PHARMA LTD520eb58058ff12fceb4eb69f7d41f9c90069518d176f64b0745b4b32102864b9
1571A202239005AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAUROBINDO PHARMA LTDEQ 10MG BASE;20MGAB["AB"]2012-09-05Sep 5, 2012NoNoNoRXAUROBINDO PHARMA LTD29ce31bc0e1223a3b5c3c6ccb58942b82db834a14c0e15290a42a115da3730d8
1572A202239006AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAUROBINDO PHARMA LTDEQ 10MG BASE;40MGAB["AB"]2012-09-05Sep 5, 2012NoNoNoRXAUROBINDO PHARMA LTDa8056d73b6b8cfbbcfaf0c001f65adf20873750138669008d102195b9202801b
1573A077215001AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDECIPLAEQ 2.5MG BASE;10MG[]2018-12-07Dec 7, 2018NoNoNoDISCNCIPLA LTDc65236dceb51dbb38050a59da28f5fceba152ed10355e0bff9b09e1e8b922de5
1574A077215002AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDECIPLAEQ 5MG BASE;10MG[]2018-12-07Dec 7, 2018NoNoNoDISCNCIPLA LTD34be56d858a4c1ed000fe67483c47a1d7618b0a769044e12af8490c46b6fa935
1575A077215003AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDECIPLAEQ 5MG BASE;20MG[]2018-12-07Dec 7, 2018NoNoNoDISCNCIPLA LTD54aeb5f8d9effb7d7f2c123170e604fc2ed7971b7702d0afb4dbb0fc43e21381
1576A077215004AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDECIPLAEQ 10MG BASE;20MG[]2018-12-07Dec 7, 2018NoNoNoDISCNCIPLA LTDfc0db652cb2a19a6ba78bcf2d0a08a486cdbd24cbca9f3c8e8f1128e366eeb0f
1577A077183001AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDR REDDYS LABS INCEQ 2.5MG BASE;10MGAB["AB"]2010-04-15Apr 15, 2010NoNoNoRXDR REDDYS LABORATORIES INC6f8ccfa2953ec35411a229259c94a48c0f05a89c54c22c9e436f7c36c91a007a
1578A077183002AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDR REDDYS LABS INCEQ 5MG BASE;10MGAB["AB"]2010-04-15Apr 15, 2010NoNoNoRXDR REDDYS LABORATORIES INCd73c5bddea7f26998e363a8ef3eb4f7f8520bd98bb5017ced5e447be96efb8b9
1579A077183003AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDR REDDYS LABS INCEQ 5MG BASE;20MGAB["AB"]2010-04-15Apr 15, 2010NoNoNoRXDR REDDYS LABORATORIES INC4d90de6d88965682504362ea3113f21fd40153de259bc95e9b5f50235f971e8b
1580A090149001AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDR REDDYS LABS INCEQ 5MG BASE;40MGAB["AB"]2011-07-05Jul 5, 2011NoNoNoRXDR REDDYS LABORATORIES INC11f4963dd17108189af571517153aadb5733891b906b84c38b25f8c37df0c442
1581A077183004AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDR REDDYS LABS INCEQ 10MG BASE;20MGAB["AB"]2010-04-15Apr 15, 2010NoNoNoRXDR REDDYS LABORATORIES INCa313b2261be5742d3dc6365d73daf2528d12a4c4e955690e0dd6fabc14cb4f91
1582A090149002AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDR REDDYS LABS INCEQ 10MG BASE;40MGAB["AB"]2011-07-05Jul 5, 2011NoNoNoRXDR REDDYS LABORATORIES INCc2c557ab9fac590e2afd7d01e6971358e468dda1449ffcbb5b84719f743a30c3
1583A078466001AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDELUPIN PHARMSEQ 2.5MG BASE;10MGAB["AB"]2010-02-05Feb 5, 2010NoNoNoRXLUPIN PHARMACEUTICALS INC91e2f5d7500010a38927edb01f03a77e89ef5912d9a84ef64f703a10f268b01a
1584A078466002AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDELUPIN PHARMSEQ 5MG BASE;10MGAB["AB"]2010-02-05Feb 5, 2010NoNoNoRXLUPIN PHARMACEUTICALS INC1c537ef6a2b425b113f2d342b0e98a41d053f807a116b24cf7029f3c08d14730
1585A078466003AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDELUPIN PHARMSEQ 5MG BASE;20MGAB["AB"]2010-02-05Feb 5, 2010NoNoNoRXLUPIN PHARMACEUTICALS INC3ae095c5be993b6c1e006b20fc87778dd6f753b3ffda83734700247c7bacc8da
1586A078466005AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDELUPIN PHARMSEQ 5MG BASE;40MGAB["AB"]2011-07-05Jul 5, 2011NoNoNoRXLUPIN PHARMACEUTICALS INCa1d8f2aeb4b136a7042d861d6202c042da7da7eeca55a91223445f3e7fd3f590
1587A078466004AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDELUPIN PHARMSEQ 10MG BASE;20MGAB["AB"]2010-02-05Feb 5, 2010NoNoNoRXLUPIN PHARMACEUTICALS INC37ae7c3deb1b6c9956d140a5184bb7cbfdbdf81cd50db25537febe7d6835b7fc
1588A078466006AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDELUPIN PHARMSEQ 10MG BASE;40MGAB["AB"]2011-07-05Jul 5, 2011NoNoNoRXLUPIN PHARMACEUTICALS INC0f6cdde11a6486ba7a8d3d5b192768f340e83d79a9ad2f8acbc02320f0f8e6d5
1589A077375001AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEMYLANEQ 2.5MG BASE;10MG[]2010-05-21May 21, 2010NoNoNoDISCNMYLAN PHARMACEUTICALS INC952cdd9b410e013772a3e0e5534dc3c100d86f795ba9c6200d4c75f340b55fa9
1590A077375002AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEMYLANEQ 5MG BASE;10MG[]2010-05-21May 21, 2010NoNoNoDISCNMYLAN PHARMACEUTICALS INC00c52818857f37d0f659a7e34c8aed2d74d692f7d221c55e68f93922d9615a46
1591A077375003AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEMYLANEQ 5MG BASE;20MG[]2010-05-21May 21, 2010NoNoNoDISCNMYLAN PHARMACEUTICALS INCff2b136f520f27947e3cd0147924466ccd989208f6fe3dd7d50496056a8067ec
1592A079047001AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEMYLANEQ 5MG BASE;40MG[]2011-07-05Jul 5, 2011NoNoNoDISCNMYLAN PHARMACEUTICALS INC69067b135adf4130f5eea09457485f54f26579b7dd47a598d22676ee7714b48b
1593A077375004AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEMYLANEQ 10MG BASE;20MG[]2010-05-21May 21, 2010NoNoNoDISCNMYLAN PHARMACEUTICALS INC7125bbded8aa113878dfdcb574b7b2d43af78db3d914bea8967095b1900222ab
1594A079047002AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEMYLANEQ 10MG BASE;40MG[]2011-07-05Jul 5, 2011NoNoNoDISCNMYLAN PHARMACEUTICALS INC8c8ab8aa64d07dc061d6e0fdee037bf4b37b4bb467cd84055bb33904e8ff4016
1595A078381001AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPAR PHARMEQ 2.5MG BASE;10MG[]2010-07-29Jul 29, 2010NoNoNoDISCNPAR PHARMACEUTICAL INCebccae57b5787a4d8d87bcd74dbc28a3017e2b903c15e21d66351c81bf72db05
1596A078381002AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPAR PHARMEQ 5MG BASE;10MG[]2010-07-29Jul 29, 2010NoNoNoDISCNPAR PHARMACEUTICAL INCa797bfe339ce8ff91f03d66cf881e8e08649be752d328b21ed10857b0570863c
1597A078381003AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPAR PHARMEQ 5MG BASE;20MG[]2010-07-29Jul 29, 2010NoNoNoDISCNPAR PHARMACEUTICAL INC9641476aeb75bb475a5bd3f4cb61c54fa8e9663f5bbdb653550a0bdf552dc2bc
1598A078381005AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPAR PHARMEQ 5MG BASE;40MG[]2010-07-29Jul 29, 2010NoNoNoDISCNPAR PHARMACEUTICAL INCcfe68320c5af2dbd55618fd1469233200c4d6712a81b9ce04b9f8af598cd489c
1599A078381004AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPAR PHARMEQ 10MG BASE;20MG[]2010-07-29Jul 29, 2010NoNoNoDISCNPAR PHARMACEUTICAL INCfc749136ee6506a9afb731a7fc6a75942eaf8dd963f308e14b3d37ad2111aac2
1600A078381006AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPAR PHARMEQ 10MG BASE;40MG[]2010-07-29Jul 29, 2010NoNoNoDISCNPAR PHARMACEUTICAL INCb8044273a44a6510213975ecd1d1fef1494c0d9712cb958e700f24a7dddf2934
1601A077179001AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDETEVA PHARMSEQ 2.5MG BASE;10MG[]2007-05-18May 18, 2007NoNoNoDISCNTEVA PHARMACEUTICALS USAedb341a1b8c49f578cb7639033205941727938f23e79459ddac3dcaeecc13d3c