Orange Book snapshot 21: Products

Products page 60 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
2952	A	040732	001	PHENYTOIN SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	EXTENDED PHENYTOIN SODIUM	WOCKHARDT USA	100MG EXTENDED		[]	2008-01-30	Jan 30, 2008	No	No	No	DISCN	WOCKHARDT USA INC	`b066fdd9335a73206d90863f2ec615c05d9b142e4cc7287836ee0d963f70bffc`
2953	N	208647	001	ROSUVASTATIN CALCIUM	CAPSULE;ORAL	CAPSULE	ORAL	EZALLOR SPRINKLE	SUN PHARMA GLOBAL	EQ 5MG BASE		[]	2018-12-18	Dec 18, 2018	No	Yes	No	RX	SUN PHARMA GLOBAL FZE	`95e61a6363a36d10da4a9baeef7656300302fc05456c26ac7c5a43954ab0f099`
2954	N	208647	002	ROSUVASTATIN CALCIUM	CAPSULE;ORAL	CAPSULE	ORAL	EZALLOR SPRINKLE	SUN PHARMA GLOBAL	EQ 10MG BASE		[]	2018-12-18	Dec 18, 2018	No	Yes	No	RX	SUN PHARMA GLOBAL FZE	`64a999413ac25da44ddc99530bdf6432c857ada178ee52921528f88eca520344`
2955	N	208647	003	ROSUVASTATIN CALCIUM	CAPSULE;ORAL	CAPSULE	ORAL	EZALLOR SPRINKLE	SUN PHARMA GLOBAL	EQ 20MG BASE		[]	2018-12-18	Dec 18, 2018	No	Yes	No	RX	SUN PHARMA GLOBAL FZE	`d58abe8c34d0ccd4982121372766b41fbceef7531c3f2a4cc0bea1c4f886bae0`
2956	N	208647	004	ROSUVASTATIN CALCIUM	CAPSULE;ORAL	CAPSULE	ORAL	EZALLOR SPRINKLE	SUN PHARMA GLOBAL	EQ 40MG BASE		[]	2018-12-18	Dec 18, 2018	No	Yes	Yes	RX	SUN PHARMA GLOBAL FZE	`d397a619ed1cdeb5eb8dae439df66bbf3365172a009344eb5c476d9add460f5b`
2957	N	205353	001	PANOBINOSTAT LACTATE	CAPSULE;ORAL	CAPSULE	ORAL	FARYDAK	SECURA	EQ 10MG BASE		[]	2015-02-23	Feb 23, 2015	No	Yes	No	RX	SECURA BIO INC	`4210e74c450fa84a8e322979e424fb5b9a4e4b04a516ae2c005b2c9dd2b806e0`
2958	N	205353	002	PANOBINOSTAT LACTATE	CAPSULE;ORAL	CAPSULE	ORAL	FARYDAK	SECURA	EQ 15MG BASE		[]	2015-02-23	Feb 23, 2015	No	Yes	No	RX	SECURA BIO INC	`bd240dee27f189748098efe494f8ccb49c1cd2a0311c92de855ba45cfe934f7b`
2959	N	205353	003	PANOBINOSTAT LACTATE	CAPSULE;ORAL	CAPSULE	ORAL	FARYDAK	SECURA	EQ 20MG BASE		[]	2015-02-23	Feb 23, 2015	No	Yes	Yes	RX	SECURA BIO INC	`7e7c6cef5a6d2e065a5f41d7767456eeea6cd270bdc891888cd7e3769f41bae6`
2960	N	017352	001	PHENTERMINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	FASTIN	GLAXOSMITHKLINE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	GLAXOSMITHKLINE	`76d84647449799a3b99e28ae961252990ce7eae0153fea0d31020d6ff8012dfd`
2961	N	018147	002	PIROXICAM	CAPSULE;ORAL	CAPSULE	ORAL	FELDENE	PFIZER	10MG	AB	["AB"]	1982-04-06	Apr 6, 1982	No	Yes	No	RX	PFIZER LABORATORIES DIV PFIZER INC	`05099c3c02d344bdffadcab35dfc29f78645929c77a3410cb73ca01080daba9f`
2962	N	018147	003	PIROXICAM	CAPSULE;ORAL	CAPSULE	ORAL	FELDENE	PFIZER	20MG	AB	["AB"]	1982-04-06	Apr 6, 1982	No	Yes	Yes	RX	PFIZER LABORATORIES DIV PFIZER INC	`965a93c8979c10801739cd14e04e53b1ad3a0c9705d4a647e3b52bb5a23de735`
2963	A	089102	001	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	CAPSULE;ORAL	CAPSULE	ORAL	FEMCET	MALLINCKRODT	325MG;50MG;40MG		[]	1985-06-19	Jun 19, 1985	No	No	No	DISCN	MALLINCKRODT CHEMICAL INC	`db1a5bac7157293e7c469839226296f7f7aa870f2b74bf40bd16ecf95dd319c1`
2964	A	201748	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE	SUN PHARM INDS LTD	43MG	AB	["AB"]	2014-10-31	Oct 31, 2014	No	No	No	RX	SUN PHARMACEUTICAL INDUSTRIES LTD	`1f9e814c8e39bb2ca5efef3dd5df7fff6d9b79c2df6d0072eb962e5b6e1386ca`
2965	A	201748	002	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE	SUN PHARM INDS LTD	130MG	AB	["AB"]	2014-10-31	Oct 31, 2014	No	No	No	RX	SUN PHARMACEUTICAL INDUSTRIES LTD	`7b8e8401cb9a8c8a1d059aa6e5cb796b3e0ebaeaa9fa482555a811634d8812fa`
2966	A	210705	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	AJANTA PHARMA LTD	67MG	AB	["AB"]	2018-09-10	Sep 10, 2018	No	No	No	RX	AJANTA PHARMA LTD	`88bd93a3e372348cdc4cd374c7d716ddf955a59239c96959aab23b0d581992b0`
2967	A	210705	002	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	AJANTA PHARMA LTD	134MG	AB	["AB"]	2018-09-10	Sep 10, 2018	No	No	No	RX	AJANTA PHARMA LTD	`9eb32e8a2d7c0f2ebb5d706b19bb7de0ec87ffa5344424b2b1470e5ac01b9cb2`
2968	A	210705	003	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	AJANTA PHARMA LTD	200MG	AB	["AB"]	2018-09-10	Sep 10, 2018	No	No	No	RX	AJANTA PHARMA LTD	`adce3846f1b30cb03e3dfd00bf3a7afe4b772c546db13d22123d68797909edc9`
2969	A	213842	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	ALEMBIC PHARMS LTD	67MG	AB	["AB"]	2020-10-19	Oct 19, 2020	No	No	No	RX	ALEMBIC PHARMACEUTICALS LTD	`fefb092874e671a77b2e4f596bc898551f4f99414f8820681d333a8ac7dfaf14`
2970	A	213842	002	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	ALEMBIC PHARMS LTD	134MG	AB	["AB"]	2020-10-19	Oct 19, 2020	No	No	No	RX	ALEMBIC PHARMACEUTICALS LTD	`22343896e6a668d8594df72978ad007c588112288ba30533add395b89c4738c9`
2971	A	213842	003	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	ALEMBIC PHARMS LTD	200MG	AB	["AB"]	2020-10-19	Oct 19, 2020	No	No	No	RX	ALEMBIC PHARMACEUTICALS LTD	`e4a142528ab38f2c0843872cfb3d52b961766459915311457f38d1ab37967c3a`
2972	A	209504	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	ANI PHARMS INC	67MG	AB	["AB"]	2018-04-30	Apr 30, 2018	No	No	No	RX	ANI PHARMACEUTICALS INC	`f20d2fe5b45376fda3761ad2934eaff42e655be8047a6c89a86673f0b1e8bb71`
2973	A	209504	002	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	ANI PHARMS INC	134MG	AB	["AB"]	2018-04-30	Apr 30, 2018	No	No	No	RX	ANI PHARMACEUTICALS INC	`0c0e4be1555fcdc9f58051cca3b24b0909169ae255bcdf854dce195e642fd1d4`
2974	A	209504	003	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	ANI PHARMS INC	200MG	AB	["AB"]	2018-04-30	Apr 30, 2018	No	No	No	RX	ANI PHARMACEUTICALS INC	`923619fe29a5666f047f418711d9f25f4d45a6729eb2b35e1c4ee44a79939b18`
2975	A	202252	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	APOTEX	43MG	AB	["AB"]	2013-07-26	Jul 26, 2013	No	No	No	RX	APOTEX INC	`efee713aa13fb8306ca20d7c8b8adde566210fe2920dbc1c6c3255a628bb0390`
2976	A	202252	002	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	APOTEX	130MG	AB	["AB"]	2013-07-26	Jul 26, 2013	No	No	No	RX	APOTEX INC	`990a65eaa0000aab573ee200ce866bc5a721ebd6046051d83a221a2046e4a787`
2977	A	207805	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	AUSTARPHARMA	67MG	AB	["AB"]	2017-11-16	Nov 16, 2017	No	No	No	RX	AUSTARPHARMA LLC	`fdd002ec46a0d37e0816546dc6d9f6a8136f2c98892aa0858d23750c2d830e26`
2978	A	207805	002	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	AUSTARPHARMA	134MG	AB	["AB"]	2017-11-16	Nov 16, 2017	No	No	No	RX	AUSTARPHARMA LLC	`cddddaccafb8e282e83546508361ebe5cf38542a8dbda238397bfaf1e8d3265b`
2979	A	207805	003	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	AUSTARPHARMA	200MG	AB	["AB"]	2017-11-16	Nov 16, 2017	No	No	No	RX	AUSTARPHARMA LLC	`598aae1645061f17bedad4bf787941a48537bb92bfbac94fc6e4d2aa35a0b157`
2980	A	090859	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	DR REDDYS LABS SA	43MG	AB	["AB"]	2012-03-01	Mar 1, 2012	No	No	No	RX	DR REDDYS LABORATORIES SA	`730b488c854b48d30cc28127c08f0ba58723e4da62d5832e096364543e40b595`
2981	A	090859	002	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	DR REDDYS LABS SA	130MG	AB	["AB"]	2012-03-01	Mar 1, 2012	No	No	No	RX	DR REDDYS LABORATORIES SA	`a217f51a24eac957a18496a973fab61556d25081e238d14a085081e1f8bff304`
2982	A	205566	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	GLENMARK PHARMS LTD	67MG	AB	["AB"]	2017-04-07	Apr 7, 2017	No	No	No	RX	GLENMARK PHARMACEUTICALS LTD	`1de34392cba90f9995f21494039b441b68ab81eb07e2a527519018b519ea5473`
2983	A	205566	002	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	GLENMARK PHARMS LTD	134MG	AB	["AB"]	2017-04-07	Apr 7, 2017	No	No	No	RX	GLENMARK PHARMACEUTICALS LTD	`d25fb6a0e27d0d9493abf4cc7c6a5a84ea41451d3920d9dbba0d917dccc15234`
2984	A	205566	003	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	GLENMARK PHARMS LTD	200MG	AB	["AB"]	2017-04-07	Apr 7, 2017	No	No	No	RX	GLENMARK PHARMACEUTICALS LTD	`8ff0160f105ce244bad1db16a0a2b454c52de39691c5de526e9d9d52436d1058`
2985	A	075868	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	IMPAX LABS	67MG	AB	["AB"]	2003-10-27	Oct 27, 2003	No	No	No	RX	IMPAX LABORATORIES INC	`a443f89c63565c408266f91fbd8a37e6e1e6c41f28147ddb9a2b5e3349fd5c81`
2986	A	075868	002	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	IMPAX LABS	134MG	AB	["AB"]	2003-10-27	Oct 27, 2003	No	No	No	RX	IMPAX LABORATORIES INC	`30f8407a573481fe8a74840905d47a5be16a77ab1cef4855f18ff6a305908136`
2987	A	075868	003	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	IMPAX LABS	200MG	AB	["AB"]	2003-10-27	Oct 27, 2003	No	No	Yes	RX	IMPAX LABORATORIES INC	`9f28fd3a3b3daf5d1cb762c4271a2cb776f2f2fec2418f3f2536879e5b05ab43`
2988	A	207378	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	INVAGEN PHARMS	67MG	AB	["AB"]	2017-03-28	Mar 28, 2017	No	No	No	RX	INVAGEN PHARMACEUTICALS INC	`61da3fd6d3c02071e6b1a971a956c4b7a140aa66aabc10c9a61253c6ba953ca7`
2989	A	207378	002	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	INVAGEN PHARMS	134MG	AB	["AB"]	2017-03-28	Mar 28, 2017	No	No	No	RX	INVAGEN PHARMACEUTICALS INC	`dc0047a6e941faf6d9b1ab7ea53448a8cdfd9392dfbc13220b7681c1d7e5f2e3`
2990	A	207378	003	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	INVAGEN PHARMS	200MG	AB	["AB"]	2017-03-28	Mar 28, 2017	No	No	No	RX	INVAGEN PHARMACEUTICALS INC	`52f15f39b3db47344c3f8a698f2174ab2a7b3716ff684f588d9e20968764dd76`
2991	A	202579	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	MYLAN PHARMS INC	43MG		[]	2013-01-10	Jan 10, 2013	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`ff703352aef21cccaf720d1bccbca11c2fd95b7803534883b5a1826f27a227dd`
2992	A	202676	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	MYLAN PHARMS INC	67MG	AB	["AB"]	2012-10-23	Oct 23, 2012	No	No	No	RX	MYLAN PHARMACEUTICALS INC	`05f612eef19c3478b5fc824a19a9a533c129d5f8183a7002948afdf9abee0ab2`
2993	A	202579	002	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	MYLAN PHARMS INC	130MG		[]	2013-01-10	Jan 10, 2013	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`10a88b4665af730f624cf6fa31131e07cd6ed2c542041c1ba47bc3d8bbb077e0`
2994	A	202676	002	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	MYLAN PHARMS INC	134MG	AB	["AB"]	2012-10-23	Oct 23, 2012	No	No	No	RX	MYLAN PHARMACEUTICALS INC	`aecb223e723d15fd440faafba0f6bd0561a3958f19ae3318b4b74a29d6b2cd87`
2995	A	202676	003	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	MYLAN PHARMS INC	200MG	AB	["AB"]	2012-10-23	Oct 23, 2012	No	No	No	RX	MYLAN PHARMACEUTICALS INC	`7774273f53b12a531431dceba43b2d310a74f6b871f230276edb52cf3c4ae3e6`
2996	A	207564	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	NOVAST LABS	67MG		[]	2019-04-19	Apr 19, 2019	No	No	No	DISCN	NOVAST LABORATORIES LTD	`5b46d9d189f8f89323b01ac0ad36bb71698538b14ba9e78ee6ba5da422f4c2ec`
2997	A	207564	002	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	NOVAST LABS	134MG		[]	2019-04-19	Apr 19, 2019	No	No	No	DISCN	NOVAST LABORATORIES LTD	`e971e0d2914100c51ff6a46774f2b72489aefc92d32b7a1e91e08e7605179357`
2998	A	207564	003	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	NOVAST LABS	200MG		[]	2019-04-19	Apr 19, 2019	No	No	No	DISCN	NOVAST LABORATORIES LTD	`bfbe5d768ab575fd72dcb8b543d046a3185e67e437db484ada4dd99368126e59`
2999	A	075753	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	RHODES PHARMS	67MG	AB	["AB"]	2002-09-03	Sep 3, 2002	No	No	No	RX	RHODES PHARMACEUTICALS LP	`8c76efcedfe4810aadf28176b7083245fd68cfd6f5c2ba568da54cc902edcf23`
3000	A	075753	002	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	RHODES PHARMS	134MG	AB	["AB"]	2002-04-09	Apr 9, 2002	No	No	No	RX	RHODES PHARMACEUTICALS LP	`e283ddfd7e04d4bb2bfd17b0fa3c72c05b9e0b4e6071c71851ebeeef8bf4fad8`
3001	A	075753	003	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	FENOFIBRATE (MICRONIZED)	RHODES PHARMS	200MG	AB	["AB"]	2002-04-09	Apr 9, 2002	No	No	No	RX	RHODES PHARMACEUTICALS LP	`bb5df0db34835eecf8257bc0b5646b55373ed7277de4dd31509057e253853f3f`