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Orange Book snapshot 21: Products

Products page 22 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
1052A078458002METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMETHYLPHENIDATE HYDROCHLORIDEMAYNE PHARMA30MGAB1["AB1"]2011-12-01Dec 1, 2011NoNoNoRXMAYNE PHARMA LLC03bdde941b203e3f641b8a4bceacd7fa0aa7eba02f8630b590ea0c75b9b04a10
1053A078458003METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMETHYLPHENIDATE HYDROCHLORIDEMAYNE PHARMA40MGAB1["AB1"]2011-12-01Dec 1, 2011NoNoNoRXMAYNE PHARMA LLCa68134cd028362b9a3fb480cc41b999e4cd8b0d23d2c330994a7bc1b608dda92
1054A078458004METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMETHYLPHENIDATE HYDROCHLORIDEMAYNE PHARMA60MGAB1["AB1"]2016-06-23Jun 23, 2016NoNoYesRXMAYNE PHARMA LLC2175f19ed93ec36699f25d0f9cc2d12c91623fb7d2743af0f1c92f624a54a6a6
1055A203583001METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMETHYLPHENIDATE HYDROCHLORIDESPECGX LLC10MGAB2["AB2"]2015-09-29Sep 29, 2015NoNoNoRXSPECGX LLCc8c3f07de65ea6826be1bf737316d796452b52188f5dfd42f4a6eff6446336c2
1056A203583002METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMETHYLPHENIDATE HYDROCHLORIDESPECGX LLC20MGAB2["AB2"]2015-09-29Sep 29, 2015NoNoNoRXSPECGX LLC4047a50cd8141bb6a9eb1b1f063f3ba9ad1d2159ad436ead7c0368e3d214b25c
1057A203583003METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMETHYLPHENIDATE HYDROCHLORIDESPECGX LLC30MGAB2["AB2"]2015-09-29Sep 29, 2015NoNoNoRXSPECGX LLCd712794476a2919b888a22f34b452ca00c5be4782278ad25be085b2eaa236066
1058A203583004METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMETHYLPHENIDATE HYDROCHLORIDESPECGX LLC40MGAB2["AB2"]2015-09-29Sep 29, 2015NoNoNoRXSPECGX LLC309b82e9d233ff0967687198ab0d2127abc1b803a9844ed97d173f668cb8bde0
1059A203583005METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMETHYLPHENIDATE HYDROCHLORIDESPECGX LLC50MGAB2["AB2"]2015-09-29Sep 29, 2015NoNoNoRXSPECGX LLCe9a7920a044a5c73b465dc1230d82622f88596d231673a4abe415390ccd2fbd9
1060A203583006METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMETHYLPHENIDATE HYDROCHLORIDESPECGX LLC60MGAB2["AB2"]2015-09-29Sep 29, 2015NoNoNoRXSPECGX LLCc30ff79c4b5360735b04cf1d7793e6777d0901544ce38ad6687bf35a31e1f578
1061A077707001METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMETHYLPHENIDATE HYDROCHLORIDETEVA PHARMS10MGAB2["AB2"]2012-07-19Jul 19, 2012NoNoNoRXTEVA PHARMACEUTICALS USAec2f4876fb1d63015ec3e4933d30f896d4e965a66780ded0fe38152b32839c8b
1062A077707002METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMETHYLPHENIDATE HYDROCHLORIDETEVA PHARMS20MGAB2["AB2"]2012-07-19Jul 19, 2012NoNoNoRXTEVA PHARMACEUTICALS USAfc46ff78aa4732da0ae9459dc82bebdc033e8272402cce8c6bfda453c6867b08
1063A077707003METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMETHYLPHENIDATE HYDROCHLORIDETEVA PHARMS30MGAB2["AB2"]2012-07-19Jul 19, 2012NoNoNoRXTEVA PHARMACEUTICALS USA054738b6c865a82857a443d65b0bfc98c53282b0a74d58e246b7752020a4c38b
1064A078873001METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMETHYLPHENIDATE HYDROCHLORIDETEVA PHARMS40MGAB2["AB2"]2012-07-19Jul 19, 2012NoNoNoRXTEVA PHARMACEUTICALS USAa85c4e27ce3e87a72ded0b799849a2ab81accb9bc64dc6740c9d676970657269
1065A078873002METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMETHYLPHENIDATE HYDROCHLORIDETEVA PHARMS50MGAB2["AB2"]2012-07-19Jul 19, 2012NoNoNoRXTEVA PHARMACEUTICALS USA0ab626d7d8f50f9f2eddec65b670da673e0bb15715717a712f0b8831cb3e28c0
1066A078873003METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMETHYLPHENIDATE HYDROCHLORIDETEVA PHARMS60MGAB2["AB2"]2012-07-19Jul 19, 2012NoNoNoRXTEVA PHARMACEUTICALS USAc73a18535d4720ac9a453b12d63e551be6473fbf4bc689cc2f9eb57b536f097e
1067N018238001POTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMICRO-KNESHER PHARMS8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNNESHER PHARMACEUTICALS USA LLCb52859ed2d25978db930849da25fe5150c5cec4aff1f30bd23329158b0195df6
1068N018238002POTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMICRO-K 10NESHER PHARMS10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1984-05-14May 14, 1984NoYesNoDISCNNESHER PHARMACEUTICALS USA LLC3e6f0f083e493caff8037f6733ab92f0b472acfbc26f88a56edc2286cec8128f
1069A079040001MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEACTAVIS ELIZABETH30MG[]2013-01-16Jan 16, 2013NoNoNoRXACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC9149b54f4a414b3a4259cb69d3322f0b9b2580f76c9ca2ae01154d3de93ffa72
1070A079040002MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEACTAVIS ELIZABETH45MG[]2013-01-16Jan 16, 2013NoNoNoRXACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INCde97c5f13d36e889165fa97f31c18655c7da77611d9407716ab51c29beae0efe
1071A079040003MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEACTAVIS ELIZABETH60MG[]2013-01-16Jan 16, 2013NoNoNoRXACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC294edf9d752f9feec3d2ae23c2312f101210d69617590da16d716b365b086cae
1072A079040004MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEACTAVIS ELIZABETH75MG[]2013-01-16Jan 16, 2013NoNoNoRXACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC3a4ebc20445ed9760974b97b53f5117600aba99609a0159af4eb8782e90329e6
1073A079040005MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEACTAVIS ELIZABETH90MG[]2013-01-16Jan 16, 2013NoNoNoRXACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC37eb3c979a6a5f8e6cb03e7244a1f983462b52f7538a61ca6d1838b232d39591
1074A079040006MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEACTAVIS ELIZABETH120MG[]2013-01-16Jan 16, 2013NoNoYesRXACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC56cb850c6a6444925508474fdd9b6849a842471a356f0183b0b1a0230d2e0881
1075A200411001MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEIMPAX LABS INC20MGAB["AB"]2016-04-12Apr 12, 2016NoNoNoRXIMPAX LABORATORIES INC241502ec6a2da6ec515b10f4a23566f375993d38f38f15e01788eae8b60f2fbf
1076A200411002MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEIMPAX LABS INC30MGAB["AB"]2016-04-12Apr 12, 2016NoNoNoRXIMPAX LABORATORIES INC93be6eb0e57b0e586e20971be4b1ea138d3557bdda925d2d7d83a010a3c9899f
1077A200411007MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEIMPAX LABS INC40MGAB["AB"]2018-07-25Jul 25, 2018NoNoNoRXIMPAX LABORATORIES INCbb487146d2c892dd2cd0f4c5266ba80df315d381e6c2ef13e66f9de93ad9c3fd
1078A200411003MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEIMPAX LABS INC50MGAB["AB"]2016-04-12Apr 12, 2016NoNoNoRXIMPAX LABORATORIES INCd3e2259794dad66ae1c25dbbb27e1ca72081ee8a960aa778a82edd59a60530d5
1079A200411004MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEIMPAX LABS INC60MGAB["AB"]2016-04-12Apr 12, 2016NoNoNoRXIMPAX LABORATORIES INC1acffb860ffce97869518797e6a4cb90b5e7dd1207fd3d9453af47ed6ee124a9
1080A200411005MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEIMPAX LABS INC80MGAB["AB"]2016-04-12Apr 12, 2016NoNoNoRXIMPAX LABORATORIES INC2395bebf73eefcd8cf055c5dde6e3b5ade74960a7064e8db48204ee2c734af48
1081A200411006MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEIMPAX LABS INC100MGAB["AB"]2016-04-12Apr 12, 2016NoNoNoRXIMPAX LABORATORIES INC16e794db3aac11540e4e6e9f9d891de3d2ec58b06c8ccf3c1564271a2a7019b4
1082A200812001MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEPAR PHARM INC20MG[]2011-11-10Nov 10, 2011NoNoNoDISCNPAR PHARMACEUTICAL INC5f97ae2fdd15bebd8f77be84cc9bac0ad5ee3d96c98263f8cd2bf68b860dcf03
1083A200812002MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEPAR PHARM INC30MG[]2011-11-10Nov 10, 2011NoNoNoDISCNPAR PHARMACEUTICAL INCf79f5046b53ff514548ec2f6cf693641800e5a774fb0d8cecbc4350b2a2a5cb0
1084A200812003MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEPAR PHARM INC50MG[]2011-11-10Nov 10, 2011NoNoNoDISCNPAR PHARMACEUTICAL INC7444da8d9ac649fc4e1243888defc6a63395ba59fc3c173ef2a7bf4d146a5519
1085A200812004MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEPAR PHARM INC60MG[]2011-11-10Nov 10, 2011NoNoNoDISCNPAR PHARMACEUTICAL INC30394d9678c44710874b350cdfe906e756f374323bd8cca09630b8bdf2354210
1086A200812005MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEPAR PHARM INC80MG[]2011-11-10Nov 10, 2011NoNoNoDISCNPAR PHARMACEUTICAL INCab9db58b8cd40b90b7cb815d69164ab9baa0eecaa2884edf79499ec03f5aaad1
1087A200812006MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEPAR PHARM INC100MG[]2011-11-10Nov 10, 2011NoNoNoDISCNPAR PHARMACEUTICAL INC3d74639f76d07948c6d59b3496f34ade7a8bd6dc5062c3d82d8493b0f6986db3
1088A202718001MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATETEVA PHARMS USA20MG[]2014-12-29Dec 29, 2014NoNoNoDISCNTEVA PHARMACEUTICALS USAa9675c4e191ce5af4bc1bbc431e45bf56d031d0b89d7ea49af78adf7409f17f5
1089A202718002MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATETEVA PHARMS USA30MG[]2014-12-29Dec 29, 2014NoNoNoDISCNTEVA PHARMACEUTICALS USA860f93a0037970510490cf116530ece4a233edb94f07bedd3f912bb658c6b4f9
1090A202718007MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATETEVA PHARMS USA40MG[]2015-06-03Jun 3, 2015NoNoNoDISCNTEVA PHARMACEUTICALS USAb49b07f5ebaf1311462d76b2ecbe9f7043664ce880ee88821f88494e0454ce2e
1091A202718003MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATETEVA PHARMS USA50MG[]2014-12-29Dec 29, 2014NoNoNoDISCNTEVA PHARMACEUTICALS USA9c6b1b997af681a8838a5a3053fab1c69993bf34cdd81d41a9dc7d493b99b08a
1092A202718004MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATETEVA PHARMS USA60MG[]2014-12-29Dec 29, 2014NoNoNoDISCNTEVA PHARMACEUTICALS USAcec488af71dcdd69ac48aba06b1565c3f670ea5a57c46746900edd904d56cdd5
1093A202718008MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATETEVA PHARMS USA70MG[]2015-06-03Jun 3, 2015NoNoNoDISCNTEVA PHARMACEUTICALS USA77d0004402bbac15a147145fe8d35bbc7cc8d61ea0d9cc56c42559f2de7a1cca
1094A202718005MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATETEVA PHARMS USA80MG[]2014-12-29Dec 29, 2014NoNoNoDISCNTEVA PHARMACEUTICALS USA7be951d420b45f3e35ca3e13c74665a28ae3945abcf8081ae86e49f1a4f70c13
1095A202718006MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATETEVA PHARMS USA100MG[]2014-12-29Dec 29, 2014NoNoNoDISCNTEVA PHARMACEUTICALS USA7225c8cbeabf9e7b4100ab4e57252741efc7e1237583dd0457761b1d726412ce
1096A202104001MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEUPSHER SMITH LABS10MGAB["AB"]2013-06-03Jun 3, 2013NoNoNoRXUPSHER SMITH LABORATORIES LLC9dc03e78e695872a94526973ae6b7cb817df3f7344ff54c2b444291e760c68bb
1097A202104002MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEUPSHER SMITH LABS20MGAB["AB"]2013-06-03Jun 3, 2013NoNoNoRXUPSHER SMITH LABORATORIES LLC960e1d109ce0bafa20c54e7598ccfa03338d82a056a02e131913d6f22b715879
1098A202104003MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEUPSHER SMITH LABS30MGAB["AB"]2013-06-03Jun 3, 2013NoNoNoRXUPSHER SMITH LABORATORIES LLC343ab4b687b27efed5d437b7a3114a17dd74c340b24f126838fdf312205afc20
1099A202104004MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEUPSHER SMITH LABS50MGAB["AB"]2013-06-03Jun 3, 2013NoNoNoRXUPSHER SMITH LABORATORIES LLC88b729b0d7b07c4d84fb8ef3cd734998c993153870c5550b8198e45a509b16f0
1100A202104005MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEUPSHER SMITH LABS60MGAB["AB"]2013-06-03Jun 3, 2013NoNoNoRXUPSHER SMITH LABORATORIES LLCf80c55f02ba623bb9665a2adb51b22996e1a45778ed00cb49e507acc34bc658b
1101A202104006MORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALMORPHINE SULFATEUPSHER SMITH LABS80MGAB["AB"]2013-06-03Jun 3, 2013NoNoNoRXUPSHER SMITH LABORATORIES LLCffd2606d6b3310d61de7ea2c37e7c66f05c11342fe6046eb9db5a6ef76ea8e6c