Orange Book snapshot 21: Products

Products page 37 of 799 · 39,901 matching rows.

Source row, Application type, Application number table
Source row	Application type	Application number	Product number	Ingredient raw	Dosage form / route raw	Dosage form	Route	Trade name	Applicant	Strength raw	TE raw	TE JSON	Approval date	Approval date raw	Approved before 1982	RLD	RS	Product type	Applicant full name	Raw row SHA-256
1802	N	016948	003	LEVODOPA	CAPSULE;ORAL	CAPSULE	ORAL	BENDOPA	VALEANT PHARM INTL	100MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	VALEANT PHARMACEUTICALS INTERNATIONAL	`79cc5d7654b318e68e013fc8c48334cf4eba57188e19b436cb4c5452c68d4765`
1803	N	016948	001	LEVODOPA	CAPSULE;ORAL	CAPSULE	ORAL	BENDOPA	VALEANT PHARM INTL	250MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	VALEANT PHARMACEUTICALS INTERNATIONAL	`56621178be83f75ed6a874840461a3646c90af6f9d3e5a75c545cefc434e101e`
1804	N	016948	002	LEVODOPA	CAPSULE;ORAL	CAPSULE	ORAL	BENDOPA	VALEANT PHARM INTL	500MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	VALEANT PHARMACEUTICALS INTERNATIONAL	`776c865d08ca807e58795a7104fc63caaf01cff2cbfeb7378e6a500e00fc9300`
1805	N	007409	003	DICYCLOMINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	BENTYL	ALLERGAN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1984-10-15	Oct 15, 1984	No	Yes	No	DISCN	ALLERGAN SALES LLC	`f912f3b0189a340ef0e747b771446cb3f7b6efeef88cacfd0fc8cd52e76fa71e`
1806	A	040682	001	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	ALEMBIC LABS	100MG	AA	["AA"]	2007-07-30	Jul 30, 2007	No	No	No	RX	ALEMBIC LABS LLC	`91db921fcaf1588d74e9fca15f625c0df7b081423bdd72805c4d014f049629d4`
1807	A	040682	002	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	ALEMBIC LABS	200MG	AA	["AA"]	2007-07-30	Jul 30, 2007	No	No	No	RX	ALEMBIC LABS LLC	`8ceea0b8091bec6524722a130addc05c4a26a0693df51949fe19d3025551ecec`
1808	A	091310	001	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	APOTEX INC	100MG	AA	["AA"]	2015-01-16	Jan 16, 2015	No	No	No	RX	APOTEX INC	`241ec780d404ccbd62f59d1c96705f56e8f95e7235d7fd982df4a172fed52620`
1809	A	091310	002	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	APOTEX INC	200MG	AA	["AA"]	2015-01-16	Jan 16, 2015	No	No	No	RX	APOTEX INC	`71839ac8f45ed81cc3fb321ca772bd6da0b15323c949eb3bf4a558504b615ced`
1810	A	211518	001	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	ASCENT PHARMS INC	100MG	AA	["AA"]	2019-02-22	Feb 22, 2019	No	No	No	RX	ASCENT PHARMACEUTICALS INC	`f4d5e188219e69d6bfd2d702a8577e81ce659d92d2dceab79b2f8b623dd558ab`
1811	A	211518	002	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	ASCENT PHARMS INC	150MG	AA	["AA"]	2019-02-22	Feb 22, 2019	No	No	No	RX	ASCENT PHARMACEUTICALS INC	`18b5ebf38a70427d7cc09deca64b07bcc802a77f5b0df3de3f9ffec970cf4d9f`
1812	A	211518	003	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	ASCENT PHARMS INC	200MG	AA	["AA"]	2019-02-22	Feb 22, 2019	No	No	No	RX	ASCENT PHARMACEUTICALS INC	`ab3912ffa84d2e5432ee3641309fd8513df70fdab02c48ffe8facebd0e7f85d5`
1813	A	081297	001	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	BIONPHARMA INC	100MG	AA	["AA"]	1993-01-29	Jan 29, 1993	No	No	No	RX	BIONPHARMA INC	`b131f8e90103c48cb317a23343b2aba62f2b5ccb23af8e1a72bc8b3053a8133c`
1814	A	081297	002	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	BIONPHARMA INC	200MG	AA	["AA"]	2007-10-30	Oct 30, 2007	No	No	No	RX	BIONPHARMA INC	`b8443714bad2fd2c51081ca159b216eaf420492203971c65187d0c8ce521042a`
1815	A	202765	002	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	CSPC-NBP PHARM	100MG	AA	["AA"]	2017-08-25	Aug 25, 2017	No	No	No	RX	CSPC-NBP PHARMACEUTICAL CO LTD	`0366cb0c63017d9eef628423824df3984e614836d858353c20583d4cb76a1e03`
1816	A	202765	001	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	CSPC-NBP PHARM	200MG	AA	["AA"]	2015-07-31	Jul 31, 2015	No	No	No	RX	CSPC-NBP PHARMACEUTICAL CO LTD	`b8c71d1ffb7e43c2d1e01fc5a4c9679418207d70cd7c6b238ad1641f593dca6f`
1817	A	040851	001	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	MIKART	100MG	AA	["AA"]	2009-11-09	Nov 9, 2009	No	No	No	RX	MIKART LLC	`53c4c65d5d251e07b5b632442f189a8492d3ca50a48df98246be2e6626b52d80`
1818	A	040851	002	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	MIKART	150MG	AA	["AA"]	2009-11-09	Nov 9, 2009	No	No	No	RX	MIKART LLC	`1230fa12663ca8e2574e7069e2afdf85de4ad84ac86f4ceef7a5996eca0fe83a`
1819	A	040851	003	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	MIKART	200MG	AA	["AA"]	2009-11-09	Nov 9, 2009	No	No	No	RX	MIKART LLC	`924ff904bef43022578e2ae449be2b9c8b532a1a9f4f6bd28153f1a2ae52c8aa`
1820	A	040795	001	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	NESHER PHARMS	100MG		[]	2007-10-31	Oct 31, 2007	No	No	No	DISCN	NESHER PHARMACEUTICALS USA LLC	`5647e143f56815463056502288d54544a1c3527c84dd756bb8908bbaa1238d11`
1821	A	040795	002	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	NESHER PHARMS	200MG		[]	2007-10-31	Oct 31, 2007	No	No	No	DISCN	NESHER PHARMACEUTICALS USA LLC	`5065e0c765f73b8c18dee05b298ddae6e2aec3bc4279207ce85ea1629623b949`
1822	A	206948	001	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	PURACAP PHARM LLC	100MG	AA	["AA"]	2018-12-19	Dec 19, 2018	No	No	No	RX	PURACAP PHARMACEUTICAL LLC	`b055b6724e37f8de4d3db4a336522541809fc246d4bc29125c351367093e9c77`
1823	A	206948	002	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	PURACAP PHARM LLC	200MG	AA	["AA"]	2018-12-19	Dec 19, 2018	No	No	No	RX	PURACAP PHARMACEUTICAL LLC	`0d30285204c4e396a91cff3f5249ff21986fc801d1cb96d93ec8ea8055e222fe`
1824	A	210562	001	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	QINGDAO BAHEAL PHARM	100MG	AA	["AA"]	2018-11-09	Nov 9, 2018	No	No	No	RX	QINGDAO BAHEAL PHARMACEUTICAL CO LTD	`4b06f9420869ef99ce874a922786e215495e029f0a6edab7b5a01465752c3335`
1825	A	210562	002	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	QINGDAO BAHEAL PHARM	150MG	AA	["AA"]	2018-11-09	Nov 9, 2018	No	No	No	RX	QINGDAO BAHEAL PHARMACEUTICAL CO LTD	`0f25e49739669e8b1ec89d348d81cddc99a9f664a230fcfe1c3e87210bd222fc`
1826	A	210562	003	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	QINGDAO BAHEAL PHARM	200MG	AA	["AA"]	2018-11-09	Nov 9, 2018	No	No	No	RX	QINGDAO BAHEAL PHARMACEUTICAL CO LTD	`87185dc7d2e827a17d90246e16b84ba7675021f2bde8bb5b174086a19c4df5f5`
1827	A	091133	001	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	STRIDES PHARMA	100MG	AA	["AA"]	2015-07-30	Jul 30, 2015	No	No	No	RX	STRIDES PHARMA GLOBAL PTE LTD	`ead65d71fdf964ecb6092c6ab1efcff7904abf46a202bd9f988115919da27e3e`
1828	A	091133	002	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	STRIDES PHARMA	200MG	AA	["AA"]	2015-07-30	Jul 30, 2015	No	No	No	RX	STRIDES PHARMA GLOBAL PTE LTD	`2ba16ab418ec845ba1f040957a291e2838f4f2c12db8ff2acb4095422e28c555`
1829	A	040587	001	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	SUN PHARM INDS INC	100MG		[]	2008-03-19	Mar 19, 2008	No	No	No	DISCN	SUN PHARMACEUTICAL INDUSTRIES INC	`47d0917a5be94e3cd7a8f3eb46c0bd666962ddc6f7505a651a04e737a739b323`
1830	A	040587	002	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	SUN PHARM INDS INC	200MG		[]	2008-03-19	Mar 19, 2008	No	No	No	DISCN	SUN PHARMACEUTICAL INDUSTRIES INC	`82abadeb5bb214a16314811956194dac6efaae6080b4e34b4a8fe25e0a7c3705`
1831	A	040627	001	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	THEPHARMANETWORK LLC	100MG	AA	["AA"]	2007-03-30	Mar 30, 2007	No	No	Yes	RX	THEPHARMANETWORK LLC	`21c5320eb52a9797bf6e27c8c477a0d94dcf8ed93c0ef6920ca9b5c5636e1463`
1832	A	201209	001	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	THEPHARMANETWORK LLC	150MG	AA	["AA"]	2014-09-24	Sep 24, 2014	No	No	Yes	RX	THEPHARMANETWORK LLC	`83f4b014449bf942d9c85dfbb2bd52436f974440fa0a361d2dbb7d74df83a20c`
1833	A	040749	001	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	THEPHARMANETWORK LLC	200MG	AA	["AA"]	2007-07-25	Jul 25, 2007	No	No	Yes	RX	THEPHARMANETWORK LLC	`5bf462b4e2a3140b29708fc6b321c5ed23d1303ca902e681b3697532c398273d`
1834	A	040597	001	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	ZYDUS PHARMS USA	100MG	AA	["AA"]	2007-06-08	Jun 8, 2007	No	No	No	RX	ZYDUS PHARMACEUTICALS USA INC	`b9e63eb6bc2890ebe2408bdce976acef31e12f0dbb1abb85d3a10e794771e57d`
1835	A	040597	002	BENZONATATE	CAPSULE;ORAL	CAPSULE	ORAL	BENZONATATE	ZYDUS PHARMS USA	200MG	AA	["AA"]	2007-06-08	Jun 8, 2007	No	No	No	RX	ZYDUS PHARMACEUTICALS USA INC	`c331d013a95f791d98acb7864f1b644488d4de69a9a37cc5a3cd0467eb49c24c`
1836	N	208383	001	BETRIXABAN	CAPSULE;ORAL	CAPSULE	ORAL	BEVYXXA	PORTOLA PHARMS INC	40MG		[]	2017-06-23	Jun 23, 2017	No	Yes	No	DISCN	PORTOLA PHARMACEUTICALS INC	`6e8920e436b0fe39a49959db82c593b3b06a0e9d4dbfd9e4328f9b08ac53a24c`
1837	N	208383	002	BETRIXABAN	CAPSULE;ORAL	CAPSULE	ORAL	BEVYXXA	PORTOLA PHARMS INC	80MG		[]	2017-06-23	Jun 23, 2017	No	Yes	No	DISCN	PORTOLA PHARMACEUTICALS INC	`4418c208647d2dc3f8d2f599dc0bb00b6414f9de833f269d170f98c251727fd2`
1838	A	210105	001	BEXAROTENE	CAPSULE;ORAL	CAPSULE	ORAL	BEXAROTENE	AMNEAL PHARMS NY	75MG	AB	["AB"]	2018-09-04	Sep 4, 2018	No	No	No	RX	AMNEAL PHARMACEUTICALS OF NY LLC	`ec03f5d2bcd50ef182c9711d3cd022477aed7816288199813245c77cf0300969`
1839	A	209861	001	BEXAROTENE	CAPSULE;ORAL	CAPSULE	ORAL	BEXAROTENE	ANI PHARMS INC	75MG	AB	["AB"]	2018-05-08	May 8, 2018	No	No	No	RX	ANI PHARMACEUTICALS INC	`d95c59bc4d0f15b42fbfa8e4a09ab331a77a1d8f6ee8c6f21692642c391878f5`
1840	A	203174	001	BEXAROTENE	CAPSULE;ORAL	CAPSULE	ORAL	BEXAROTENE	BIONPHARMA INC	75MG	AB	["AB"]	2014-08-12	Aug 12, 2014	No	No	No	RX	BIONPHARMA INC	`605810920c11ba1554d95341bdf0fa3fe654827f05e4efb8ac86e58fa7a6bbfd`
1841	A	203663	001	BEXAROTENE	CAPSULE;ORAL	CAPSULE	ORAL	BEXAROTENE	HIKMA	75MG	AB	["AB"]	2020-06-16	Jun 16, 2020	No	No	No	RX	HIKMA PHARMACEUTICALS USA INC	`8f93aefa6d5dfe692f096e2e050102d21d21e772465ce5fa6ae6c1a1b9a07cac`
1842	A	209931	001	BEXAROTENE	CAPSULE;ORAL	CAPSULE	ORAL	BEXAROTENE	TEVA PHARMS USA	75MG	AB	["AB"]	2021-01-14	Jan 14, 2021	No	No	No	RX	TEVA PHARMACEUTICALS USA	`9456688a9c2af6ec251a318557e931274c6034f1550ff9201c0d07a334f89e02`
1843	A	209886	001	BEXAROTENE	CAPSULE;ORAL	CAPSULE	ORAL	BEXAROTENE	UPSHER SMITH LABS	75MG	AB	["AB"]	2018-07-25	Jul 25, 2018	No	No	No	RX	UPSHER SMITH LABORATORIES LLC	`e29410f8a38ce31bddcded065d4520d892133044647318650890bc2578455b74`
1844	N	210132	001	ESTRADIOL; PROGESTERONE	CAPSULE;ORAL	CAPSULE	ORAL	BIJUVA	THERAPEUTICSMD INC	1MG;100MG		[]	2018-10-28	Oct 28, 2018	No	Yes	Yes	RX	THERAPEUTICSMD INC	`6b18638e0f27740f63682fc9f17893b6b40164f8293331a268103cc64a277f74`
1845	A	087768	001	IPODATE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	BILIVIST	BAYER HLTHCARE	500MG		[]	1982-08-11	Aug 11, 1982	No	No	No	DISCN	BAYER HEALTHCARE PHARMACEUTICALS INC	`953fcee566b23346f779540d9e151f7e700c05293a3a8af996f7ba19da9348fb`
1846	N	013731	001	TYROPANOATE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	BILOPAQUE	GE HEALTHCARE	750MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	GE HEALTHCARE	`103b058d6ec97bf9304743821dbcfd0c07eecf231eb73b9dc6b200f7f66267a1`
1847	N	210496	001	ENCORAFENIB	CAPSULE;ORAL	CAPSULE	ORAL	BRAFTOVI	ARRAY BIOPHARMA INC	50MG		[]	2018-06-27	Jun 27, 2018	No	Yes	No	DISCN	ARRAY BIOPHARMA INC	`b0a997691e48ad6995bb016b5ee22d99afa0b4789517d968ebabf3ed8d181592`
1848	N	210496	002	ENCORAFENIB	CAPSULE;ORAL	CAPSULE	ORAL	BRAFTOVI	ARRAY BIOPHARMA INC	75MG		[]	2018-06-27	Jun 27, 2018	No	Yes	Yes	RX	ARRAY BIOPHARMA INC	`a9d9b7228c1bfe9b1bca3ae5cbb9a30e88274d962631f6d3d180698f85a6799b`
1849	N	204516	001	PAROXETINE MESYLATE	CAPSULE;ORAL	CAPSULE	ORAL	BRISDELLE	SEBELA IRELAND LTD	EQ 7.5MG BASE	AB	["AB"]	2013-06-28	Jun 28, 2013	No	Yes	Yes	RX	SEBELA IRELAND LTD	`90850b0015cd48f59376f854b30b9b7c6d10df6a13a7db95bcdc570eca9df835`
1850	A	061658	001	TETRACYCLINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	BRISTACYCLINE	BRISTOL	250MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO	`ad3dce610c60b5bc883e71b2ef643a3816025aa2800361bdb53e18f0d12d2348`
1851	A	061888	001	TETRACYCLINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	BRISTACYCLINE	BRISTOL	250MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO	`bdee01741a99d9b7af5e4c67c1ec3ac36788ad767b488135fd2f01fa3857591b`