← Snapshot 21

Orange Book snapshot 21: Products

Products page 11 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
502N205831001METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAPTENSIO XRRHODES PHARMS10MGAB3["AB3"]2015-04-17Apr 17, 2015NoYesNoRXRHODES PHARMACEUTICALS LP15ff0f26784c4c42c148a5e184c65d355e02df8d47ad79bca5e5283d22bbab94
503N205831002METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAPTENSIO XRRHODES PHARMS15MGAB3["AB3"]2015-04-17Apr 17, 2015NoYesNoRXRHODES PHARMACEUTICALS LP51e92911d606667ac3330968477a3f7dbc44241aac9e69048cbbf36effb96485
504N205831003METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAPTENSIO XRRHODES PHARMS20MGAB3["AB3"]2015-04-17Apr 17, 2015NoYesNoRXRHODES PHARMACEUTICALS LPbef3811c1c595aa435203107b9c11dacb443da0806de2ff10295ab624805104d
505N205831004METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAPTENSIO XRRHODES PHARMS30MGAB3["AB3"]2015-04-17Apr 17, 2015NoYesNoRXRHODES PHARMACEUTICALS LPc6468bf3dc00afdd29e1d4894e5c88b43d2c9ce639f15e3d234fd43f089820c9
506N205831005METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAPTENSIO XRRHODES PHARMS40MGAB3["AB3"]2015-04-17Apr 17, 2015NoYesNoRXRHODES PHARMACEUTICALS LP3c800bcc8e3fb70a6ddc5c51df2ee9ddfde67e43bba4a1642892444ddf94dd0a
507N205831006METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAPTENSIO XRRHODES PHARMS50MGAB3["AB3"]2015-04-17Apr 17, 2015NoYesNoRXRHODES PHARMACEUTICALS LP688c278732ee2d66d8000a2dc80481938a051117b36512cbb3a90826e9bcdf4a
508N205831007METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAPTENSIO XRRHODES PHARMS60MGAB3["AB3"]2015-04-17Apr 17, 2015NoYesYesRXRHODES PHARMACEUTICALS LP703bc56104ab8bd8a5ccaf9a980d432ea8f386f244286a05fd50eb99eaaa4df5
509N006773010TRIHEXYPHENIDYL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALARTANELEDERLE5MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNLEDERLE LABORATORIES DIV AMERICAN CYANAMID CO62b79b036160b1288f9c72f68758a814c13fbf4852e4c55e2126ca559eb492aa
510N012947001TRIHEXYPHENIDYL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALARTANELEDERLE5MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNLEDERLE LABORATORIES DIV AMERICAN CYANAMID CO4bd84678d530f5157f45813922ce135b4087c775aa48052bb89c7868066ade9f
511A206392001ASPIRIN; DIPYRIDAMOLECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALASPIRIN AND DIPYRIDAMOLEAMNEAL PHARMS25MG;200MGAB["AB"]2016-03-08Mar 8, 2016NoNoNoRXAMNEAL PHARMACEUTICALS OF NEW YORK LLC6773aa4f65462340513794d0d76444222671fbe727e303a952f981110c5fd752
512A206964001ASPIRIN; DIPYRIDAMOLECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALASPIRIN AND DIPYRIDAMOLEANI PHARMS INC25MG;200MG[]2017-01-18Jan 18, 2017NoNoNoDISCNANI PHARMACEUTICALS INCcabfa9a23fb82ec08d07ec91e2df82dfcd0cffe3b8e70df3edcb3df606d4623f
513A078804001ASPIRIN; DIPYRIDAMOLECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALASPIRIN AND DIPYRIDAMOLEBARR25MG;200MGAB["AB"]2009-08-14Aug 14, 2009NoNoNoRXBARR LABORATORIES INCd0201dd3dffaf4739853e0ddbca7838450274689ab068e8b7fe5a56fc53b8288
514A209048001ASPIRIN; DIPYRIDAMOLECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALASPIRIN AND DIPYRIDAMOLEDR REDDYS25MG;200MGAB["AB"]2018-10-10Oct 10, 2018NoNoNoRXDR REDDYS LABORATORIES LTD5307bc026e80a9fd6b9096cea706a20e659ee361ff7068d8150037235ed4e34c
515A210318001ASPIRIN; DIPYRIDAMOLECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALASPIRIN AND DIPYRIDAMOLEGLENMARK PHARMS SA25MG;200MGAB["AB"]2019-05-24May 24, 2019NoNoNoRXGLENMARK PHARMACEUTICALS SA SWITZERLAND0a92d4d24e24874227128220b041b6eb8904c63b3e8bae3eac21677194fdc8d6
516A204552001ASPIRIN; DIPYRIDAMOLECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALASPIRIN AND DIPYRIDAMOLELANNETT CO INC25MG;200MGAB["AB"]2019-03-20Mar 20, 2019NoNoNoRXLANNETT CO INC5f5f15cd7aedca5fccdac6ef8422bce648efd2ff0d4cd090e8353e32c77482bd
517A207944001ASPIRIN; DIPYRIDAMOLECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALASPIRIN AND DIPYRIDAMOLEPAR PHARM INC25MG;200MGAB["AB"]2017-01-18Jan 18, 2017NoNoNoRXPAR PHARMACEUTICAL INCf75db905f04a1f3766f9630d315f8b07e85a3cd54551d9fff97938ead6a99201
518A206739001ASPIRIN; DIPYRIDAMOLECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALASPIRIN AND DIPYRIDAMOLESANDOZ INC25MG;200MGAB["AB"]2017-01-18Jan 18, 2017NoNoNoRXSANDOZ INC2662423f1f421b85a795e9c9a4d7fe055e354779daaceb5fb246bb0e6d9aaa31
519A208572001ASPIRIN; DIPYRIDAMOLECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALASPIRIN AND DIPYRIDAMOLESUN PHARM25MG;200MGAB["AB"]2018-08-21Aug 21, 2018NoNoNoRXSUN PHARMACEUTICAL INDUSTRIES LTD0c7303a2646c8270e02bd02af5953fa3ae250471979252b7fd0875f6ffad9208
520A206753001ASPIRIN; DIPYRIDAMOLECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALASPIRIN AND DIPYRIDAMOLEZYDUS PHARMS25MG;200MGAB["AB"]2017-08-29Aug 29, 2017NoNoNoRXZYDUS PHARMACEUTICALS USA INC2b24caaefe44f12ec18385627b98a3a84609adf184db95e42caf00f0bb7dd59c
521N204096001TACROLIMUSCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALASTAGRAF XLASTELLASEQ 0.5MG BASE[]2013-07-19Jul 19, 2013NoYesNoRXASTELLAS PHARMA US INC2fda5a52e5c5af644db141eb7440eef4fbc2997e9a9be5c206feec55f6f8690d
522N204096002TACROLIMUSCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALASTAGRAF XLASTELLASEQ 1MG BASE[]2013-07-19Jul 19, 2013NoYesNoRXASTELLAS PHARMA US INC3f11ffb39f26f138d02e18c60db54cbf97c2f81ef845f051ba1580d07bf32510
523N204096003TACROLIMUSCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALASTAGRAF XLASTELLASEQ 5MG BASE[]2013-07-19Jul 19, 2013NoYesYesRXASTELLAS PHARMA US INC798ae832c30666d5d62e6c2e29d7bc97776f2de15c5bcf88fbfeb7784b92d193
524N021260001MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAVINZAKING PHARMS LLC30MG[]2002-03-20Mar 20, 2002NoNoNoDISCNKING PHARMACEUTICALS LLCba1fe57f02ea68cd07103be7f760d13ec96be3416c499f527c4be6bde00a414d
525N021260005MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAVINZAKING PHARMS LLC45MG[]2008-12-18Dec 18, 2008NoNoNoDISCNKING PHARMACEUTICALS LLCaa3f1ac3eba7baa0052ddf3079b6ab4b26ceda82fdbfab1ed31a856824f0f59e
526N021260002MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAVINZAKING PHARMS LLC60MG[]2002-03-20Mar 20, 2002NoNoNoDISCNKING PHARMACEUTICALS LLC44450131010f55e60e074904b0c859354dd6229e586a34645d0b11d0968e3007
527N021260006MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAVINZAKING PHARMS LLC75MG[]2008-12-18Dec 18, 2008NoNoNoDISCNKING PHARMACEUTICALS LLC99fc56381a63ee458daf44db0bf672209acbb254a21c1532de4400bec9331694
528N021260003MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAVINZAKING PHARMS LLC90MG[]2002-03-20Mar 20, 2002NoNoNoDISCNKING PHARMACEUTICALS LLCe6518819423c9dc5c6f10c5a54801db23d38287edb3cd6069c66c0f70301a8ca
529N021260004MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALAVINZAKING PHARMS LLC120MG[]2002-03-20Mar 20, 2002NoNoNoDISCNKING PHARMACEUTICALS LLCf151f1c22ca91271f59921792311e1acdd47e0ce8ca239222551873bd7155eae
530N010093007AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEXCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALBIPHETAMINE 12.5UCB INCEQ 6.25MG BASE;EQ 6.25MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNUCB INCe9ed2a3a67c9baef468371a073b68542c36def8be6a3c2c6eabfc6b0f81bd002
531N010093003AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEXCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALBIPHETAMINE 20UCB INCEQ 10MG BASE;EQ 10MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNUCB INC7a43bcf244eeae01d8622b5a46ac8440fab4827fca74eebd7a14e7f3e6a6f16d
532N010093009AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEXCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALBIPHETAMINE 7.5UCB INCEQ 3.75MG BASE;EQ 3.75MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNUCB INCda3dabeabff880d7f3c7ed53750740023ac785c00a457ad5dfbd303f8fdd12d8
533A088021001PHENDIMETRAZINE TARTRATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALBONTRILVALEANT105MG[]1982-09-21Sep 21, 1982NoNoNoDISCNVALEANT PHARMACEUTICALS INTERNATIONAL6067466a8c1c389be5587c4453ea1c757d79d4d3da521455aa658a6911eb369a
534A078986001CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARBAMAZEPINEAPOTEX INC100MGAB["AB"]2011-11-25Nov 25, 2011NoNoNoRXAPOTEX INC2e744fef2c70cbbbfcb423f47d7c62cf0c6dcb72431ddfbf98f86fcbe997b841
535A078986002CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARBAMAZEPINEAPOTEX INC200MGAB["AB"]2011-11-25Nov 25, 2011NoNoNoRXAPOTEX INC344f163c3b673c80bb717bbb3c37b4883bd09b76d6e16d337e8421c3400632dd
536A078986003CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARBAMAZEPINEAPOTEX INC300MGAB["AB"]2011-11-25Nov 25, 2011NoNoNoRXAPOTEX INC95957e03583b0665a3cb1eb2bb821ad4e0750d50c6250f7a9ba75fbe5f3b94c5
537A076697001CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARBAMAZEPINENOSTRUM LABS INC100MGAB["AB"]2011-05-20May 20, 2011NoNoNoRXNOSTRUM LABORATORIES INCb1e49d46f837d182a8fce74ffb614bbefdd8dbef873f44e70d16bc7eb208f10e
538A076697002CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARBAMAZEPINENOSTRUM LABS INC200MGAB["AB"]2011-05-20May 20, 2011NoNoNoRXNOSTRUM LABORATORIES INC3b10f01a046330f4a8f62ada4b47d058cde8f84d8dc6093566feae038575e0d6
539A076697003CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARBAMAZEPINENOSTRUM LABS INC300MGAB["AB"]2011-05-20May 20, 2011NoNoNoRXNOSTRUM LABORATORIES INC5e5d2c8e69d7bddb8b3ce01e03f20817a48913e22286196527e31408b4f8d006
540A201106001CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARBAMAZEPINETARO100MGAB["AB"]2013-06-21Jun 21, 2013NoNoNoRXTARO PHARMACEUTICAL INDUSTRIES LTD76b713985acca920e9e4c874d899b31d1b1dd8c68cb6b208214ca2359c68d4fb
541A201106002CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARBAMAZEPINETARO200MGAB["AB"]2013-06-21Jun 21, 2013NoNoNoRXTARO PHARMACEUTICAL INDUSTRIES LTDc670d58814a4507e89c94f11d8899377c278d3ff3d1b430d942504f28922cf41
542A201106003CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARBAMAZEPINETARO300MGAB["AB"]2013-06-21Jun 21, 2013NoNoNoRXTARO PHARMACEUTICAL INDUSTRIES LTDea495dc0a92286ff8c4f3b54d3724272d5740a9ffb9756981f2be1911cca6ec8
543A078592001CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARBAMAZEPINETEVA PHARMS100MGAB["AB"]2012-09-20Sep 20, 2012NoNoNoRXTEVA PHARMACEUTICALS USAcf750e98613486cd8d9d98e616caca88f7c50ccb641a77ad8e5a1450853080a5
544A078592002CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARBAMAZEPINETEVA PHARMS200MGAB["AB"]2012-09-20Sep 20, 2012NoNoNoRXTEVA PHARMACEUTICALS USA2e0f1e8b6bd199f3cbb6129134024980d603a2b14d344f03d27ae67a0b753b9e
545A078592003CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARBAMAZEPINETEVA PHARMS300MGAB["AB"]2012-09-20Sep 20, 2012NoNoNoRXTEVA PHARMACEUTICALS USA8c517e4ef26ae38dd872349b0d629a9a80925f6cd81975a0451d62f281f5f799
546N020712003CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARBATROLTAKEDA PHARMS USA100MGAB["AB"]1997-09-30Sep 30, 1997NoYesNoRXTAKEDA PHARMACEUTICALS USA INC370e7d9ec06ee97ffdcf443ad48ca49552d383f2c0274dc558ea1e154aef8972
547N020712001CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARBATROLTAKEDA PHARMS USA200MGAB["AB"]1997-09-30Sep 30, 1997NoYesNoRXTAKEDA PHARMACEUTICALS USA INCcd1d7fb0223bbe6a9aa5cb9e7c830b96250fc8b11353eda41b255f22bfe73d6f
548N020712002CARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARBATROLTAKEDA PHARMS USA300MGAB["AB"]1997-09-30Sep 30, 1997NoYesYesRXTAKEDA PHARMACEUTICALS USA INC52da47a3a15810a327446d8ff3da4a5dee166eed2ce3bd8ea417538652b94818
549N020005001NICARDIPINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARDENE SRCHIESI30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1992-02-21Feb 21, 1992NoYesNoDISCNCHIESI USA INCda93630b2ac91cb8cb9500dd9d3d2018b9048dc9e570baba19552a00e1e64177
550N020005002NICARDIPINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARDENE SRCHIESI45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1992-02-21Feb 21, 1992NoYesNoDISCNCHIESI USA INC314e54742b74d583e7cddfc21890da8ae48e189a2a388969b01c2c81f26c879f
551N020005003NICARDIPINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALCARDENE SRCHIESI60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1992-02-21Feb 21, 1992NoYesNoDISCNCHIESI USA INC0b17032edb7c9ef8e9247329a613aaa3889854e405f909a885d82fab4e69768c