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Orange Book snapshot 21: Products

Products page 34 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
1652A061755001AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATEMYLANEQ 250MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNMYLAN PHARMACEUTICALS INC9c9d3363ec929b5ab75bdb553c05cd19ff3eb544438b1fc582a40e2bd78af6cf
1653A061755002AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATEMYLANEQ 500MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNMYLAN PHARMACEUTICALS INCad9b9e3e342a3cb886df5c52efabf6f1f0b9e8a0c7a7f1c6926eda2655c3c074
1654A061853001AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATEPUREPAC PHARMEQ 250MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNPUREPAC PHARMACEUTICAL COf86c7e078972eb207feb46e1ade50610a412e53526bcdd245563a14ce810ebf3
1655A061853002AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATEPUREPAC PHARMEQ 500MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNPUREPAC PHARMACEUTICAL CO77d203e84ca510e9075eb7359d93a5eb3923a0d52c506e1e37db9f9fe8d1a37d
1656A064082001AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATESANDOZEQ 250MG BASE[]1995-08-29Aug 29, 1995NoNoNoDISCNSANDOZ INCcb3b602c85f4c362e8cc9bfccb2151a7e14678f98a92c07e9403016ec9075f66
1657A064082002AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATESANDOZEQ 500MG BASE[]1995-08-29Aug 29, 1995NoNoYesRXSANDOZ INC2c373809ed3002226b1d4ebc970a3d15503fe73c4e1827c82c2f491dd453e74f
1658A061387001AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATEVITARINEEQ 250MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNVITARINE PHARMACEUTICALS INC1defb3296b5cb52bb646c74ebbe4914bde46b051b9c2d0da88d2d17c4623823a
1659A061387003AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALAMPICILLIN TRIHYDRATEVITARINEEQ 500MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNVITARINE PHARMACEUTICALS INC432d4ac8155138e3aa0359efbbeb7a8d6e924bf057d691b3b29846b00bd17c7b
1660N019906001CLOMIPRAMINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAFRANILSPECGX LLC25MGAB["AB"]1989-12-29Dec 29, 1989NoYesYesRXSPECGX LLC69a7c916d12825d08313228d611e1484bb80d15ef4a5719c3920f815d3d88b4d
1661N019906002CLOMIPRAMINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAFRANILSPECGX LLC50MGAB["AB"]1989-12-29Dec 29, 1989NoYesNoRXSPECGX LLCb6c3ade0351054027dcde9cd0f18d7f9822aa1f0112867f2476125e425460dfb
1662N019906003CLOMIPRAMINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAFRANILSPECGX LLC75MGAB["AB"]1989-12-29Dec 29, 1989NoYesNoRXSPECGX LLC0fea2a3b0147e71393867c82ebb99c7a7f40d8b87aa746c231de7669bee06733
1663A076530001ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEBARREQ 0.5MG BASE[]2005-04-18Apr 18, 2005NoNoNoDISCNBARR LABORATORIES INCe28a4674f85018d9396868bd00633159913beaf34d1d4ba7a4d3eaa7b59f551b
1664A076530002ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEBARREQ 1MG BASE[]2005-04-18Apr 18, 2005NoNoNoDISCNBARR LABORATORIES INCcc457d40422e65d35396b383a7ae4fb528b2ffe7c30bb4f429198a2e002aaeb5
1665A076910001ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEIMPAX LABSEQ 0.5MG BASEAB["AB"]2005-04-18Apr 18, 2005NoNoNoRXIMPAX LABORATORIES INCaa08badff2f4f95e0f6e42606214bec77b5c819562f3f300c01615a91e4db437
1666A076910002ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEIMPAX LABSEQ 1MG BASEAB["AB"]2005-04-18Apr 18, 2005NoNoNoRXIMPAX LABORATORIES INC868a8d4cf44ba5559c597e33c74b60ac4d6f73e08f64517a18bdb637e9edfbcb
1667A076468001ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEIVAX SUB TEVA PHARMSEQ 0.5MG BASEAB["AB"]2005-04-18Apr 18, 2005NoNoNoRXIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA469099ee5516efe22aa55bbb478f5fd37367b37d0c425c3945e9c0932cf07a01
1668A076468002ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEIVAX SUB TEVA PHARMSEQ 1MG BASEAB["AB"]2005-04-18Apr 18, 2005NoNoYesRXIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA30eff70b2cf52caed082480d323c5539d62dda2aaac04c2327cae5e922917b07
1669A076811001ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEMYLANEQ 0.5MG BASE[]2005-04-18Apr 18, 2005NoNoNoDISCNMYLAN PHARMACEUTICALS INC461c1eb7e29d62f7200a796ae7d73ae331c405f9f67c7205818be06bcba49ddc
1670A076811002ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEMYLANEQ 1MG BASE[]2005-04-18Apr 18, 2005NoNoNoDISCNMYLAN PHARMACEUTICALS INC6c106fd8267b56bb6c635896b751a087e572bb0af537edcd8e39ecd07915a5f7
1671A077613001ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEMYLAN PHARMS INCEQ 0.5MG BASE[]2006-06-27Jun 27, 2006NoNoNoDISCNMYLAN PHARMACEUTICALS INC75634add05efeb64cdbd1628a2df79a7f0ca4b84de8fa02371f71e207668c1e2
1672A077613002ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEMYLAN PHARMS INCEQ 1MG BASE[]2006-06-27Jun 27, 2006NoNoNoDISCNMYLAN PHARMACEUTICALS INC500d529bd6ae209764e63fffcfcc0d8f6ed5956206c0cb696104cc5e7f3dea8f
1673A076489001ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEROXANEEQ 0.5MG BASE[]2005-04-18Apr 18, 2005NoNoNoDISCNROXANE LABORATORIES INC6e0e3ec88de394eb7fbd4204d7572a2eca88bcd033625fc615644b6ce81c1313
1674A076489002ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEROXANEEQ 1MG BASE[]2005-04-18Apr 18, 2005NoNoNoDISCNROXANE LABORATORIES INCf6f48bd86b489bf97adfe0ac077a1e2d4359cc9812473783949e74f3f7a10fb0
1675A209151001ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDETORRENTEQ 0.5MG BASEAB["AB"]2017-06-30Jun 30, 2017NoNoNoRXTORRENT PHARMACEUTICALS LTD344f5c39659a20f64a389a3594918f64e5b3604bf081307e90f3e756c16ee3e6
1676A209151002ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDETORRENTEQ 1MG BASEAB["AB"]2017-06-30Jun 30, 2017NoNoNoRXTORRENT PHARMACEUTICALS LTD932a0fc4433b1121bff15bc0e51ecc873ce560dd4dc660fffbff4490583ed145
1677A076683001ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEUPSHER SMITH LABSEQ 0.5MG BASE[]2005-04-18Apr 18, 2005NoNoNoDISCNUPSHER SMITH LABORATORIES LLC931df9d76a9de2358c362a81b4123431562ce51ab0eef0c08a72d1924791875a
1678A076683002ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEUPSHER SMITH LABSEQ 1MG BASE[]2005-04-18Apr 18, 2005NoNoNoDISCNUPSHER SMITH LABORATORIES LLC93ef778851d04a020182a0b92a778c7e97886aad24f9ebb2562e9962257eb687
1679A076417001ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEWATSON LABSEQ 0.5MG BASE[]2005-04-18Apr 18, 2005NoNoNoDISCNWATSON LABORATORIESb26747a7f8906ff0acdd767e9c0d6d206fc9871509d57d1474916266549600f9
1680A076417002ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALANAGRELIDE HYDROCHLORIDEWATSON LABSEQ 1MG BASE[]2005-04-18Apr 18, 2005NoNoNoDISCNWATSON LABORATORIESe80ca98b0147d104d1d59957869333668845e7789fba917592a0ddfe28277059
1681N017001001FLUCYTOSINECAPSULE;ORALCAPSULEORALANCOBONBAUSCH250MGAB["AB"]Approved Prior to Jan 1, 1982YesYesNoRXBAUSCH HEALTH US LLC521bb56090c82c4bd7e180aa4095a8789cfc7e667c4582499beaa151f666ae50
1682N017001002FLUCYTOSINECAPSULE;ORALCAPSULEORALANCOBONBAUSCH500MGAB["AB"]Approved Prior to Jan 1, 1982YesYesYesRXBAUSCH HEALTH US LLCdeb1557404391b330ed6c45103f783d1ad359e16851eafd5eaf9f04086f417b3
1683A087628001ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORALCAPSULEORALANOQUANSHIRE325MG;50MG;40MG[]1986-10-01Oct 1, 1986NoNoNoDISCNSHIRE DEVELOPMENT INCc7bceb14ddd4cd96b70968155a7451241f2d70074f60f4c1e4e93fc882513d75
1684A061859001CEPHRADINECAPSULE;ORALCAPSULEORALANSPORGLAXOSMITHKLINE250MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNGLAXOSMITHKLINEfd32db0836bee252f386e7b6ecafbc932006b39f2544a1023cc6abfa57c76708
1685A061859002CEPHRADINECAPSULE;ORALCAPSULEORALANSPORGLAXOSMITHKLINE500MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNGLAXOSMITHKLINE6d4b0b784378714ae762f2dd5c43c421169e17d31711ac64f919bdc3add26cd1
1686N021695004FENOFIBRATECAPSULE;ORALCAPSULEORALANTARA (MICRONIZED)LUPIN30MG[]2013-10-18Oct 18, 2013NoYesNoRXLUPIN INC10110cd456741325bd6abf5e701f600d73cdfd4420ebccc1d55b091e6a34788b
1687N021695001FENOFIBRATECAPSULE;ORALCAPSULEORALANTARA (MICRONIZED)LUPIN43MGAB["AB"]2004-11-30Nov 30, 2004NoYesNoRXLUPIN INC913ca4ac424831e71b7f615f51a1201395441945940953c57ab482766bb25f49
1688N021695002FENOFIBRATECAPSULE;ORALCAPSULEORALANTARA (MICRONIZED)LUPIN87MG[]2004-11-30Nov 30, 2004NoNoNoDISCNLUPIN INC16f41c6a513ffdc05c50247c05c180d7f727e0dd247d80b60d3e4f58246c76cd
1689N021695005FENOFIBRATECAPSULE;ORALCAPSULEORALANTARA (MICRONIZED)LUPIN90MG[]2013-10-18Oct 18, 2013NoYesYesRXLUPIN INC9a1e7cc0eeea27117527a4c141644df2df2a72d7ab9f2cbd1780f250d9ccf223
1690N021695003FENOFIBRATECAPSULE;ORALCAPSULEORALANTARA (MICRONIZED)LUPIN130MGAB["AB"]2004-11-30Nov 30, 2004NoYesYesRXLUPIN INCac4fd4c4fc36ff1f7cbbcbcadd0607956ac032b164c2eea8a06d494557ea9d00
1691N011556004SULFINPYRAZONECAPSULE;ORALCAPSULEORALANTURANENOVARTIS200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNNOVARTIS PHARMACEUTICALS CORPe31fc9146f5429cab62ef4208446a749874398c5912fe077e301955a58bb9baa
1692A207777001APREPITANTCAPSULE;ORALCAPSULEORALAPREPITANTGLENMARK PHARMS SA40MGAB["AB"]2017-10-12Oct 12, 2017NoNoNoRXGLENMARK PHARMACEUTICALS SA SWITZERLAND815e7bdd8502feaba6eb67b2a5818289cf7544943ebb0e9aee6de3f86b6b8acc
1693A207777002APREPITANTCAPSULE;ORALCAPSULEORALAPREPITANTGLENMARK PHARMS SA80MGAB["AB"]2017-10-12Oct 12, 2017NoNoNoRXGLENMARK PHARMACEUTICALS SA SWITZERLANDde454d8594820d2140729b37a04c1ed50d7847ee34f2260d42b9459c331cea47
1694A207777003APREPITANTCAPSULE;ORALCAPSULEORALAPREPITANTGLENMARK PHARMS SA125MGAB["AB"]2017-10-12Oct 12, 2017NoNoNoRXGLENMARK PHARMACEUTICALS SA SWITZERLAND385a827b798d6a37ddce0c59b3c0d3890bbae4a2871a1a1aef837bb4d183768f
1695A090999001APREPITANTCAPSULE;ORALCAPSULEORALAPREPITANTSANDOZ40MGAB["AB"]2012-09-24Sep 24, 2012NoNoNoRXSANDOZ INC31191d6820cbe365fbca9df4bebabc2837f8745e8d9a81c782bb382de4ccb17d
1696A090999002APREPITANTCAPSULE;ORALCAPSULEORALAPREPITANTSANDOZ80MGAB["AB"]2012-09-24Sep 24, 2012NoNoNoRXSANDOZ INCedb7f3ff65f51abb663c7de7b68622c8c56a79a359c8883b8632bcf2d86037bd
1697A090999003APREPITANTCAPSULE;ORALCAPSULEORALAPREPITANTSANDOZ125MGAB["AB"]2012-09-24Sep 24, 2012NoNoNoRXSANDOZ INC7c4f505f3ec76e8bb1ba7a76d969d26c587da8aff89bef0667e32464e6f74741
1698A211835001APREPITANTCAPSULE;ORALCAPSULEORALAPREPITANTTORRENT40MGAB["AB"]2020-10-21Oct 21, 2020NoNoNoRXTORRENT PHARMA INCd3bcca800b47b90013e3582960696e101392caa072d773da87a155482aae77f2
1699A211835002APREPITANTCAPSULE;ORALCAPSULEORALAPREPITANTTORRENT80MGAB["AB"]2020-10-21Oct 21, 2020NoNoNoRXTORRENT PHARMA INCd795d32ba3b4c4b5431f4727b491399c3bdf6502ac94564b0530482509f34b37
1700A211835003APREPITANTCAPSULE;ORALCAPSULEORALAPREPITANTTORRENT125MGAB["AB"]2020-10-21Oct 21, 2020NoNoNoRXTORRENT PHARMA INCbac97b9503430ea12eda528d59549ec192bba9545061b38976d484e4e7c5adb7
1701A084735001HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDECAPSULE;ORALCAPSULEORALAPRESAZIDENOVARTIS25MG;25MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNNOVARTIS PHARMACEUTICALS CORPaa3561660c67f293f37977c35c4e692280043d5437663af3978439cfd3186e51