← Snapshot 21

Orange Book snapshot 21: Products

Products page 25 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
1202A078703004PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEADARE PHARMS INC160MGAB["AB"]2011-07-15Jul 15, 2011NoNoNoRXADARE PHARMACEUTICALS INC8b1fad9efed6090e0eb6e98b38ec357863271fd98aae985b57b7c0d00dcd99c3
1203A212026001PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEAMTA60MGAB["AB"]2020-01-06Jan 6, 2020NoNoNoRXAMTA LABS LTD47b5a7f501044ee8833404e869bac486698e253b834be634b30be5ea4e4e751e
1204A212026002PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEAMTA80MGAB["AB"]2020-01-06Jan 6, 2020NoNoNoRXAMTA LABS LTD88d318d74cd3b52087bdcd5175b02ea75315755688b2395025d9a049bc9244fa
1205A212026003PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEAMTA120MGAB["AB"]2020-01-06Jan 6, 2020NoNoNoRXAMTA LABS LTD5e0b026cd73c3b8bd931ca6234cbdde949436435c3576d341375594945d74a4a
1206A212026004PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEAMTA160MGAB["AB"]2020-01-06Jan 6, 2020NoNoNoRXAMTA LABS LTD0fb37491d86f9107af9946e35af1183ab11420bcf884fd4d0d07edef7a21448a
1207A072499001PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEINWOOD LABS60MG[]1989-04-11Apr 11, 1989NoNoNoDISCNINWOOD LABORATORIES INC SUB FOREST LABORATORIES INC0dc122884df5cb0aebf55a06cbf4cc327bdab2be9e8cf14b2ff2362c9a92cb50
1208A072500001PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEINWOOD LABS80MG[]1989-04-11Apr 11, 1989NoNoNoDISCNINWOOD LABORATORIES INC SUB FOREST LABORATORIES INCb60efe70024688f551c0ddfb5ac6cb67d985cc43aa650b1e92aa358e88033275
1209A072501001PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEINWOOD LABS120MG[]1989-04-11Apr 11, 1989NoNoNoDISCNINWOOD LABORATORIES INC SUB FOREST LABORATORIES INC159fab0d843f6f44f1ddf6f87b192581621c4b956b3acda49e7bd297261ffa5c
1210A072502001PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEINWOOD LABS160MG[]1989-04-11Apr 11, 1989NoNoNoDISCNINWOOD LABORATORIES INC SUB FOREST LABORATORIES INC2694d8a6fab4c43df9b64fc627c0683b532ce4e8b981971f170a64e8d30bcf75
1211A078022001PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEMYLAN60MG[]2007-02-15Feb 15, 2007NoNoNoDISCNMYLAN PHARMACEUTICALS INC521c912b280e5a5df6b49c80f0bec36beeb661197ac25a3385db75284954384e
1212A078022002PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEMYLAN80MG[]2007-02-15Feb 15, 2007NoNoNoDISCNMYLAN PHARMACEUTICALS INCf16405fa01823d3aae0eea34344e4dd1a2f11eefeba2f65c4ddbdda2249d5b00
1213A078022003PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEMYLAN120MG[]2007-02-15Feb 15, 2007NoNoNoDISCNMYLAN PHARMACEUTICALS INCebe4b0b7dbb444395ba7f707c832310e97ab1479b797e219f83418b164cfd1ec
1214A078022004PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEMYLAN160MG[]2007-02-15Feb 15, 2007NoNoNoDISCNMYLAN PHARMACEUTICALS INC51f4612d8e9fc68da77ca3308b241b7e1d2df7542a002761961d57ba37880892
1215A078065001PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDENORTEC DEV ASSOC60MGAB["AB"]2007-01-26Jan 26, 2007NoNoNoRXNORTEC DEVELOPMENT ASSOC INCeac57ca1a20abaee391d7177d74829605c475c6cadd77d261948d056a5bda832
1216A078065002PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDENORTEC DEV ASSOC80MGAB["AB"]2007-01-26Jan 26, 2007NoNoNoRXNORTEC DEVELOPMENT ASSOC INC2c4c8face77c051b0e6d60c88ccf9bc5034bdd5215669b177843e52ce69dfcd2
1217A078065003PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDENORTEC DEV ASSOC120MGAB["AB"]2007-01-26Jan 26, 2007NoNoNoRXNORTEC DEVELOPMENT ASSOC INC91ae6da4a2daa2242a322a4bd25eee93f2e50fcce20dd6688f2dd1cf8cae7b36
1218A078065004PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDENORTEC DEV ASSOC160MGAB["AB"]2007-01-26Jan 26, 2007NoNoNoRXNORTEC DEVELOPMENT ASSOC INC72d108dba284a1cd15c539829fd638afde32b838a9e20768757e41e6bd95744d
1219A078311001PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEUPSHER SMITH LABS60MG[]2009-03-06Mar 6, 2009NoNoNoDISCNUPSHER SMITH LABORATORIES LLC7616b0e9bed423253c09a2a4ecd4ee6b3fd0234d8f429668e396583a8757307a
1220A078311002PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEUPSHER SMITH LABS80MG[]2009-03-06Mar 6, 2009NoNoNoDISCNUPSHER SMITH LABORATORIES LLC4e9d62a6e12927466eb81e084e1bc2315e2cfbd5beefbda5027373a66bf60598
1221A078311003PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEUPSHER SMITH LABS120MG[]2009-03-06Mar 6, 2009NoNoNoDISCNUPSHER SMITH LABORATORIES LLC45763b12f28a4b86cdbb390f9ca8a18d537f2fe8f208f8888d4c2557d073272a
1222A078311004PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEUPSHER SMITH LABS160MG[]2009-03-06Mar 6, 2009NoNoNoDISCNUPSHER SMITH LABORATORIES LLCcd0b6b361cf26267ed27a283b8e6a7d22cb90a9989983e70aa0fa006e1afe8be
1223A090321001PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEZYDUS PHARMS USA INC60MGAB["AB"]2011-03-25Mar 25, 2011NoNoNoRXZYDUS PHARMACEUTICALS USA INC470f8b1fda0d6b3b73f46234fd3f15d83b590d9bd2b8b865ce927083323b600f
1224A090321002PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEZYDUS PHARMS USA INC80MGAB["AB"]2011-03-25Mar 25, 2011NoNoNoRXZYDUS PHARMACEUTICALS USA INCa0b3de598a6a92c7c33b504df6ca738b53d5d8f16020e3fbbe909f0e469d554b
1225A090321003PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEZYDUS PHARMS USA INC120MGAB["AB"]2011-03-25Mar 25, 2011NoNoNoRXZYDUS PHARMACEUTICALS USA INC52a04875d201018c7ba4c9a1a32a3b1688c396ee87bcd92abcfb93a45fa517b5
1226A090321004PROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPROPRANOLOL HYDROCHLORIDEZYDUS PHARMS USA INC160MGAB["AB"]2011-03-25Mar 25, 2011NoNoNoRXZYDUS PHARMACEUTICALS USA INC9581835e9221cb58d747c034fa1bbc6ad625ff0eecb34f5ba5ed6594a11dc5cb
1227N019428001CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATECENT PHARMS8MG;120MG[]1988-08-02Aug 2, 1988NoNoNoDISCNCENTRAL PHARMACEUTICALS INCe63a7e313ee8d9afd1374a4943985afc1d6f1afd92cffe35ecad0f7a7e2bf5ca
1228N018844001CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATEGRAHAM DM8MG;120MG[]1985-03-20Mar 20, 1985NoNoNoDISCNDM GRAHAM LABORATORIES INC2e981f9ceac93666375503e98ff377b758a3cb499f6d1e197388b2e0134d6f2b
1229N018843001CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATEGRAHAM DM12MG;120MG[]1985-03-18Mar 18, 1985NoNoNoDISCNDM GRAHAM LABORATORIES INC104ebcbac9db0d1afa3c7435521d5ca9d2f5a6b8d4268580dd35f2eea3b53824
1230A071455001CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALPSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATEKV PHARM12MG;120MG[]1989-03-01Mar 1, 1989NoNoNoDISCNKV PHARMACEUTICAL CO79da5cf82b2d9f693218c795fa1e7227592d573ddc37ef2e5b831fcfc5b0ae27
1231N022580001PHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALQSYMIAVIVUSEQ 3.75MG BASE;23MG[]2012-07-17Jul 17, 2012NoYesNoRXVIVUS INC80f045ded205e772578259481854d22215802f6fcaef4c9ef6306cd8c338f528
1232N022580002PHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALQSYMIAVIVUSEQ 7.5MG BASE;46MG[]2012-07-17Jul 17, 2012NoYesNoRXVIVUS INCfc566f4e6abd2a43d9e3bdd64009e384e3306a23aba17bdf7135bb78d1af58b8
1233N022580003PHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALQSYMIAVIVUSEQ 11.25MG BASE;69MG[]2012-07-17Jul 17, 2012NoYesNoRXVIVUS INCc656e1a5d70e47e44fb89c8f4e6cd775f173a115afebaab31d6c383eec334a09
1234N022580004PHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALQSYMIAVIVUSEQ 15MG BASE;92MG[]2012-07-17Jul 17, 2012NoYesYesRXVIVUS INC1b9d684a6db2660873bed25085f13be263490fe36614f6b3d51a7b309e59c29a
1235N205122001TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALQUDEXY XRUPSHER SMITH LABS25MGAB2["AB2"]2014-03-11Mar 11, 2014NoYesNoRXUPSHER SMITH LABORATORIES LLC84bdae2b0015a556ebb4f9876e4f3bebee7fd3d1fbf19ddff2cf44a0438a112c
1236N205122002TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALQUDEXY XRUPSHER SMITH LABS50MGAB2["AB2"]2014-03-11Mar 11, 2014NoYesNoRXUPSHER SMITH LABORATORIES LLC58dd3e525a70cc544818adfff7f6e8c98c8fc832f6f80047d3b7f0c85bb62a33
1237N205122003TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALQUDEXY XRUPSHER SMITH LABS100MGAB2["AB2"]2014-03-11Mar 11, 2014NoYesNoRXUPSHER SMITH LABORATORIES LLC63d9093b5ddf802b45f1ec467d2c04337894f03c921093df10220fe67c2677c7
1238N205122004TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALQUDEXY XRUPSHER SMITH LABS150MGAB2["AB2"]2014-03-11Mar 11, 2014NoYesNoRXUPSHER SMITH LABORATORIES LLCc931c7cc2b4d91b5ba4a8e700e388adb626764a12366936e93191db401aa5866
1239N205122005TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALQUDEXY XRUPSHER SMITH LABS200MGAB2["AB2"]2014-03-11Mar 11, 2014NoYesYesRXUPSHER SMITH LABORATORIES LLC455a8962ec819eccc7ad7e02a5e1521a3846dd7ffe7e236e8e9f0ab468126685
1240N208010001CALCIFEDIOLCAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRAYALDEEEIRGEN0.03MG[]2016-06-17Jun 17, 2016NoYesYesRXEIRGEN PHARMA LTD9bfe5291bce479c63a19c838ce2b4f3e08389e056fa5ece95ab373e9482f2f10
1241N021615001GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRAZADYNE ERJANSSEN PHARMSEQ 8MG BASEAB["AB"]2005-04-01Apr 1, 2005NoYesYesRXJANSSEN PHARMACEUTICALS INCabbe5761aeec29b8716a894212ba4fb91b64fa08970d79ce8cdca00f1332b174
1242N021615002GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRAZADYNE ERJANSSEN PHARMSEQ 16MG BASEAB["AB"]2005-04-01Apr 1, 2005NoYesNoRXJANSSEN PHARMACEUTICALS INCd71504a38cad482ab79ed19001e6c39c26ced3315612c1aaa1d017a2ebf4729a
1243N021615003GALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRAZADYNE ERJANSSEN PHARMSEQ 24MG BASEAB["AB"]2005-04-01Apr 1, 2005NoYesNoRXJANSSEN PHARMACEUTICALS INC164fbf1c833604f2fa679eb1d62204df31d537be5a17165e15ab41eb002364ec
1244N021284004METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRITALIN LANOVARTIS10MGAB1["AB1"]2004-04-10Apr 10, 2004NoYesNoRXNOVARTIS PHARMACEUTICALS CORP5df9d9a5cfec2e42cfa5c2b65e08e12e63b0eeaf3a21dbe2a697b9018ef8f95c
1245N021284001METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRITALIN LANOVARTIS20MGAB1["AB1"]2002-06-05Jun 5, 2002NoYesNoRXNOVARTIS PHARMACEUTICALS CORPeeaf5098d38b63ba8946b461960dc611965644cedac6340ff49b0f413929a0e6
1246N021284002METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRITALIN LANOVARTIS30MGAB1["AB1"]2002-06-05Jun 5, 2002NoYesNoRXNOVARTIS PHARMACEUTICALS CORPcdda0d9be3b13366a349698d830596a072562953bd2530b5fb63df1163c10d13
1247N021284003METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRITALIN LANOVARTIS40MGAB1["AB1"]2002-06-05Jun 5, 2002NoYesNoRXNOVARTIS PHARMACEUTICALS CORP4eb8ef39e860dffa2a4fdafbf47a0d0f31217ff6166e60bfde61362700ed6ea2
1248N021284005METHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRITALIN LANOVARTIS60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]2014-10-27Oct 27, 2014NoYesNoDISCNNOVARTIS PHARMACEUTICALS CORPd9b48614435cfc230daa080615cde9f5d46a93dd08e69fea98318e4a0fc34742
1249N203312001CARBIDOPA; LEVODOPACAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRYTARYIMPAX LABS INC23.75MG;95MG[]2015-01-07Jan 7, 2015NoYesNoRXIMPAX LABORATORIES INCfc71401f35d1fe26aa309eb9a2ea2ad252afc3f2f62f220a07011e0448075a85
1250N203312002CARBIDOPA; LEVODOPACAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRYTARYIMPAX LABS INC36.25MG;145MG[]2015-01-07Jan 7, 2015NoYesNoRXIMPAX LABORATORIES INC32d994a3562345d80bc26020e5f7be714d14b741c8c77902d085bebc947efc2e
1251N203312003CARBIDOPA; LEVODOPACAPSULE, EXTENDED RELEASE;ORALCAPSULE, EXTENDED RELEASEORALRYTARYIMPAX LABS INC48.75MG;195MG[]2015-01-07Jan 7, 2015NoYesNoRXIMPAX LABORATORIES INC833fb34ac06938aa2c83fe2d6826466c6a1f5f3f67bf1b694e2ef5483598cbc6