Orange Book snapshot 21: Products

Products page 58 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
2852	A	202530	001	DUTASTERIDE	CAPSULE;ORAL	CAPSULE	ORAL	DUTASTERIDE	RISING	0.5MG		[]	2015-11-20	Nov 20, 2015	No	No	No	DISCN	RISING PHARMA HOLDINGS INC	`5640b94a2ca4207d57c189c48e87fb7c54423a4d2e2ced7d820aba3df6f673ea`
2853	A	204262	001	DUTASTERIDE	CAPSULE;ORAL	CAPSULE	ORAL	DUTASTERIDE	STRIDES PHARMA	0.5MG	AB	["AB"]	2015-11-20	Nov 20, 2015	No	No	No	RX	STRIDES PHARMA GLOBAL PTE LTD	`75cf3bf4d8591051367b25649eb123a904048791c31c3d5088364dc78f673aab`
2854	A	208227	001	DUTASTERIDE	CAPSULE;ORAL	CAPSULE	ORAL	DUTASTERIDE	STRIDES PHARMA	0.5MG		[]	2018-06-22	Jun 22, 2018	No	No	No	DISCN	STRIDES PHARMA GLOBAL PTE LTD	`c42baee4ff7882056b2f313e0332ed76271ba0779418971f1a8c02964b7e0570`
2855	A	202421	001	DUTASTERIDE	CAPSULE;ORAL	CAPSULE	ORAL	DUTASTERIDE	VINTAGE PHARMS LLC	0.5MG	AB	["AB"]	2015-11-20	Nov 20, 2015	No	No	No	RX	VINTAGE PHARMACEUTICALS LLC	`cbdd5450d3fca2ad9cc36b65e17b995a699437f8c170dcdd4f103d586784410c`
2856	A	202975	001	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	ACTAVIS LABS FL INC	0.5MG;0.4MG		[]	2015-11-20	Nov 20, 2015	No	No	No	DISCN	ACTAVIS LABORATORIES FL INC	`d789ee58193f7780f465501fc74fffea2f065ac1427142c1239a900e6711c7c1`
2857	A	202509	001	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	ANCHEN PHARMS	0.5MG;0.4MG	AB	["AB"]	2014-02-26	Feb 26, 2014	No	No	No	RX	ANCHEN PHARMACEUTICALS INC	`6cda58f60e357cbc96664c35840eb2980c211e3db09a2315945046bebe8b02e2`
2858	A	207769	001	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	ZYDUS PHARMS	0.5MG;0.4MG	AB	["AB"]	2018-05-24	May 24, 2018	No	No	No	RX	ZYDUS PHARMACEUTICALS USA INC	`f7784018fbc44e4aa878ac8b4d8e0053711279192fffe063cfab5a3c22188682`
2859	N	016042	003	HYDROCHLOROTHIAZIDE; TRIAMTERENE	CAPSULE;ORAL	CAPSULE	ORAL	DYAZIDE	GLAXOSMITHKLINE LLC	25MG;37.5MG		[]	1994-03-03	Mar 3, 1994	No	Yes	No	DISCN	GLAXOSMITHKLINE LLC	`0a6685aab681183e520f93f2f311b9f01ad806036d6b740df9a29f1000328fc9`
2860	N	016042	002	HYDROCHLOROTHIAZIDE; TRIAMTERENE	CAPSULE;ORAL	CAPSULE	ORAL	DYAZIDE	GLAXOSMITHKLINE LLC	25MG;50MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	GLAXOSMITHKLINE LLC	`e6f12bd7c632849efb51399ca176022d2899dd69ec7eab71a5274f3bb85270b6`
2861	A	060254	002	DICLOXACILLIN SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	DYCILL	GLAXOSMITHKLINE	EQ 250MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	GLAXOSMITHKLINE	`560a5c45657c3a76b33add497cbeae80990925d2a3c9f3660eac3f021bc8cde5`
2862	A	062238	001	DICLOXACILLIN SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	DYCILL	GLAXOSMITHKLINE	EQ 250MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	GLAXOSMITHKLINE	`7e01e5736f837f6e24ba64fdd8521642fac2818ec99ff1265fa37f79a1b5f386`
2863	A	060254	003	DICLOXACILLIN SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	DYCILL	GLAXOSMITHKLINE	EQ 500MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	GLAXOSMITHKLINE	`78ad2e4070f58dbcb271bf589239f7c28f45237bd0b74a8db670963c9fd5e357`
2864	A	062238	002	DICLOXACILLIN SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	DYCILL	GLAXOSMITHKLINE	EQ 500MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	GLAXOSMITHKLINE	`e326b0b27f9c6766a030a7e1c67e360f35f142eee1f8965be99e759cd3a57625`
2865	A	063067	003	MINOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	DYNACIN	CNTY LINE PHARMS	EQ 50MG BASE	AB	["AB"]	1990-08-14	Aug 14, 1990	No	No	No	RX	COUNTY LINE PHARMACEUTICALS LLC	`19c601faf04f4780260fc9324009e39b1f903210472cf64a4db469cfe5135795`
2866	A	063067	002	MINOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	DYNACIN	CNTY LINE PHARMS	EQ 75MG BASE	AB	["AB"]	1999-09-15	Sep 15, 1999	No	No	No	RX	COUNTY LINE PHARMACEUTICALS LLC	`3f8631865f23484d9f03623b9d3f3ce5fe6ca93db59644652b1672eb46320189`
2867	A	063067	001	MINOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	DYNACIN	CNTY LINE PHARMS	EQ 100MG BASE	AB	["AB"]	1990-07-31	Jul 31, 1990	No	No	No	RX	COUNTY LINE PHARMACEUTICALS LLC	`732f52205339a6b786a36a5d61a1682eae080697f6bd1e8c36c3cbaf45a8e360`
2868	N	019546	001	ISRADIPINE	CAPSULE;ORAL	CAPSULE	ORAL	DYNACIRC	SMITHKLINE BEECHAM	2.5MG		[]	1990-12-20	Dec 20, 1990	No	Yes	No	DISCN	SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE	`5c3693a6d1613ddcc4d5c73bedfd8b11f5a9a77489e9b445927636ec43c8c42d`
2869	N	019546	002	ISRADIPINE	CAPSULE;ORAL	CAPSULE	ORAL	DYNACIRC	SMITHKLINE BEECHAM	5MG		[]	1990-12-20	Dec 20, 1990	No	Yes	No	DISCN	SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE	`5b403f1345104236a6000638ddb51c640407a579f6d3fe8b0729e9e3f40e5834`
2870	N	013174	001	TRIAMTERENE	CAPSULE;ORAL	CAPSULE	ORAL	DYRENIUM	CONCORDIA	50MG	AB	["AB"]		Approved Prior to Jan 1, 1982	Yes	Yes	No	RX	CONCORDIA PHARMACEUTICALS INC	`0cd291ab3db1082df36f38d2f7b6e9bd7e5d18492e99cd5c1d25896331cb396f`
2871	N	013174	002	TRIAMTERENE	CAPSULE;ORAL	CAPSULE	ORAL	DYRENIUM	CONCORDIA	100MG	AB	["AB"]		Approved Prior to Jan 1, 1982	Yes	Yes	Yes	RX	CONCORDIA PHARMACEUTICALS INC	`bc0218d8f13c096a44848e90f4b3417b52d705ec8adf3b352cc26096352f396a`
2872	A	078064	001	EFAVIRENZ	CAPSULE;ORAL	CAPSULE	ORAL	EFAVIRENZ	AUROBINDO PHARMA LTD	50MG	AB	["AB"]	2017-12-15	Dec 15, 2017	No	No	No	RX	AUROBINDO PHARMA LTD	`0ecfc07527ff6e469437835ea0e62a053b7bd51168d9ed29654e2ed932590aa7`
2873	A	078064	002	EFAVIRENZ	CAPSULE;ORAL	CAPSULE	ORAL	EFAVIRENZ	AUROBINDO PHARMA LTD	100MG		[]	2017-12-15	Dec 15, 2017	No	No	No	RX	AUROBINDO PHARMA LTD	`750016d25436cc19c3f6649e5d664a5ca1b7f629ec1271e57b1ab08f3e778530`
2874	A	078064	003	EFAVIRENZ	CAPSULE;ORAL	CAPSULE	ORAL	EFAVIRENZ	AUROBINDO PHARMA LTD	200MG	AB	["AB"]	2017-12-15	Dec 15, 2017	No	No	No	RX	AUROBINDO PHARMA LTD	`03c5a222977846e3399ca4b3483fa38a9d29e63b0ff15f27dfc1ad021a5951cf`
2875	N	020647	001	SELEGILINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	ELDEPRYL	SOMERSET	5MG		[]	1996-05-15	May 15, 1996	No	Yes	No	DISCN	SOMERSET PHARMACEUTICALS INC	`8cc47fa1ec722b2431c3c7ab2366ab91b88a40e342009d1b4f3742fad6d90efc`
2876	A	085545	001	THEOPHYLLINE	CAPSULE;ORAL	CAPSULE	ORAL	ELIXOPHYLLIN	FOREST LABS	100MG		[]	1984-07-31	Jul 31, 1984	No	No	No	DISCN	FOREST LABORATORIES INC	`099a681d9d664bfd8b18f445ac5f7fea2eff670115cde26506a598fcefc40eae`
2877	A	083921	001	THEOPHYLLINE	CAPSULE;ORAL	CAPSULE	ORAL	ELIXOPHYLLIN	FOREST LABS	200MG		[]	1984-07-31	Jul 31, 1984	No	No	No	DISCN	FOREST LABORATORIES INC	`c2ae72beb5e2a29aee2df244e3e26cf62510a1169609a99af4746dfb499330a2`
2878	N	020193	001	PENTOSAN POLYSULFATE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	ELMIRON	JANSSEN PHARMS	100MG		[]	1996-09-26	Sep 26, 1996	No	Yes	Yes	RX	JANSSEN PHARMACEUTICALS INC	`fb66ec3a3bba6e374a6a9b3b00f45ec723a309747b0365173b26d8afccd843e5`
2879	N	018045	001	ESTRAMUSTINE PHOSPHATE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	EMCYT	PHARMACIA AND UPJOHN	EQ 140MG PHOSPHATE		[]		Approved Prior to Jan 1, 1982	Yes	Yes	Yes	RX	PHARMACIA AND UPJOHN CO	`93e6b8e7482900e305941d00b33d232af1b92b00a4572c81e935306d500843f2`
2880	N	021549	003	APREPITANT	CAPSULE;ORAL	CAPSULE	ORAL	EMEND	MERCK	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	2006-06-30	Jun 30, 2006	No	Yes	No	DISCN	MERCK AND CO INC	`adbe64d3715a848e56508535f6e4f1f32a9598b087e2b551f28e5b0a5596a86f`
2881	N	021549	001	APREPITANT	CAPSULE;ORAL	CAPSULE	ORAL	EMEND	MERCK	80MG	AB	["AB"]	2003-03-26	Mar 26, 2003	No	Yes	No	RX	MERCK AND CO INC	`7b0c68bf8331562e18281824af91eee74555d5f3ba3ac6846d821751bd9d5fa8`
2882	N	021549	002	APREPITANT	CAPSULE;ORAL	CAPSULE	ORAL	EMEND	MERCK	125MG	AB	["AB"]	2003-03-26	Mar 26, 2003	No	Yes	Yes	RX	MERCK AND CO INC	`3f0707e0f98fe8251de1d7bb7404898bc9f42d73fe2c51cd63972651b77d768b`
2883	A	091168	001	EMTRICITABINE	CAPSULE;ORAL	CAPSULE	ORAL	EMTRICITABINE	CIPLA	200MG	AB	["AB"]	2018-07-02	Jul 2, 2018	No	No	No	RX	CIPLA LTD	`a6911fae2342b65038f51c2f210bf759d3d0a6bd0b36d532afb8dd558ff96e1d`
2884	N	021500	001	EMTRICITABINE	CAPSULE;ORAL	CAPSULE	ORAL	EMTRIVA	GILEAD	200MG	AB	["AB"]	2003-07-02	Jul 2, 2003	No	Yes	Yes	RX	GILEAD SCIENCES INC	`90a623dfc2a3f4cbabf54e4b9d5afa58883b927be631db1eb2ef4ed05df822dc`
2885	N	021775	001	ALVIMOPAN	CAPSULE;ORAL	CAPSULE	ORAL	ENTEREG	CUBIST PHARMS	12MG	AB	["AB"]	2008-05-20	May 20, 2008	No	Yes	Yes	RX	CUBIST PHARMACEUTICALS INC	`7c2c0f3b0e146f981ea2d0bffa9d6507173116aa76a0ddda58d9275fa5fbc91d`
2886	N	021324	001	BUDESONIDE	CAPSULE;ORAL	CAPSULE	ORAL	ENTOCORT EC	PERRIGO PHARMA INTL	3MG	AB	["AB"]	2001-10-02	Oct 2, 2001	No	Yes	Yes	RX	PERRIGO PHARMA INTERNATIONAL DAC	`a654b25707d5455d8cc3a80b304509dbc9edf6f08df45dd301d3563b446e4ee2`
2887	N	205060	001	OMEGA-3-CARBOXYLIC ACIDS	CAPSULE;ORAL	CAPSULE	ORAL	EPANOVA	ASTRAZENECA	1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS		[]	2014-05-05	May 5, 2014	No	Yes	No	DISCN	ASTRAZENECA PHARMACEUTICALS LP	`801fddcc1f76e8a318f989e85a758668c3bdd33c13207d703756d1842c680e15`
2888	N	012455	002	MEPROBAMATE	CAPSULE;ORAL	CAPSULE	ORAL	EQUANIL	WYETH AYERST	400MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	WYETH AYERST LABORATORIES	`fae9fb9ecb1f9bc9e95745b9e19d9fd51652e146ec9493e6f0c4cf37f0d13ed6`
2889	A	040833	001	ERGOCALCIFEROL	CAPSULE;ORAL	CAPSULE	ORAL	ERGOCALCIFEROL	ALEMBIC LABS	50,000 IU	AA	["AA"]	2009-05-20	May 20, 2009	No	No	No	RX	ALEMBIC LABS LLC	`def2f9d54d11fa20959fff93c4d72b5fb0c5efadd3474fe9c0165e7200c80272`
2890	A	204276	001	ERGOCALCIFEROL	CAPSULE;ORAL	CAPSULE	ORAL	ERGOCALCIFEROL	PURACAP PHARM LLC	50,000 IU	AA	["AA"]	2018-12-07	Dec 7, 2018	No	No	No	RX	PURACAP PHARMACEUTICAL LLC	`09b178e8379a513d9d136cf5267bb974710559ecf761e81342ea72e73e57a0fb`
2891	A	091004	001	ERGOCALCIFEROL	CAPSULE;ORAL	CAPSULE	ORAL	ERGOCALCIFEROL	SIGMAPHARM LABS LLC	50,000 IU	AA	["AA"]	2010-07-14	Jul 14, 2010	No	No	No	RX	SIGMAPHARM LABORATORIES LLC	`618cf2d2d66aec1462507ab059b07dcbe2997ff8e813925c70be1c9e83487b5b`
2892	A	090455	001	ERGOCALCIFEROL	CAPSULE;ORAL	CAPSULE	ORAL	ERGOCALCIFEROL	STRIDES PHARMA	50,000 IU	AA	["AA"]	2010-08-03	Aug 3, 2010	No	No	No	RX	STRIDES PHARMA GLOBAL PTE LTD	`90ba874372afca70c3ef21406e57086c1cad6650d4eeba164036c59f8469e3c4`
2893	A	040865	001	ERGOCALCIFEROL	CAPSULE;ORAL	CAPSULE	ORAL	ERGOCALCIFEROL	SUN PHARM INDS INC	50,000 IU	AA	["AA"]	2009-12-29	Dec 29, 2009	No	No	No	RX	SUN PHARMACEUTICAL INDUSTRIES INC	`e7e891dca0cc425509af4c9a0a57516fecef2bc3dcaf35c2411c51de3190f502`
2894	N	203388	001	VISMODEGIB	CAPSULE;ORAL	CAPSULE	ORAL	ERIVEDGE	GENENTECH	150MG		[]	2012-01-30	Jan 30, 2012	No	Yes	Yes	RX	GENENTECH INC	`4335c326b57f1747817cbfdea29e4e4594bed5e86436af9276049a41573fd244`
2895	A	062162	001	ERYTHROMYCIN ESTOLATE	CAPSULE;ORAL	CAPSULE	ORAL	ERYTHROMYCIN ESTOLATE	BARR	EQ 125MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	BARR LABORATORIES INC	`5c69479569af3ac7fdeebfc78021e545373d53baf099f1413175e6536097ebb3`
2896	A	062162	002	ERYTHROMYCIN ESTOLATE	CAPSULE;ORAL	CAPSULE	ORAL	ERYTHROMYCIN ESTOLATE	BARR	EQ 250MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	BARR LABORATORIES INC	`c603c70f2d00371b4295d75645275b7b81410078f87dab4c66effb90b8b0c4f1`
2897	A	062237	001	ERYTHROMYCIN ESTOLATE	CAPSULE;ORAL	CAPSULE	ORAL	ERYTHROMYCIN ESTOLATE	IVAX SUB TEVA PHARMS	EQ 250MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA	`1b427a224fc79e295476ce08f74b4a03af78f2f92e132651982d7653497cb504`
2898	A	062087	001	ERYTHROMYCIN ESTOLATE	CAPSULE;ORAL	CAPSULE	ORAL	ERYTHROMYCIN ESTOLATE	WATSON LABS	EQ 250MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	WATSON LABORATORIES INC	`90d2b072a46e4643a7a30b45d5764d4d1e97c753839e94171fd96de9eb761627`
2899	N	022535	001	PIRFENIDONE	CAPSULE;ORAL	CAPSULE	ORAL	ESBRIET	GENENTECH INC	267MG		[]	2014-10-15	Oct 15, 2014	No	Yes	Yes	RX	GENENTECH INC	`d78d0fb23b7130692688d7b44ac2784fba92ef6a70885a2848cac6cae0b95139`
2900	A	077660	001	ESCITALOPRAM OXALATE	CAPSULE;ORAL	CAPSULE	ORAL	ESCITALOPRAM OXALATE	MYLAN PHARMS INC	EQ 5MG BASE		[]	2007-07-31	Jul 31, 2007	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`fa810141c767f24a4a8b900dbc97999a82314cc26ff2536c10644481e32b2474`
2901	A	077660	002	ESCITALOPRAM OXALATE	CAPSULE;ORAL	CAPSULE	ORAL	ESCITALOPRAM OXALATE	MYLAN PHARMS INC	EQ 10MG BASE		[]	2007-07-31	Jul 31, 2007	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`7c4d55a75bb94659b75bfe1539de61ddefaacc4cc73edc8fd52c62cdf8be23ee`