Orange Book snapshot 21: Products

Products page 76 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
3752	N	050641	001	DOXYCYCLINE	CAPSULE;ORAL	CAPSULE	ORAL	MONODOX	CHARTWELL RX	EQ 100MG BASE		[]	1989-12-29	Dec 29, 1989	No	Yes	No	DISCN	CHARTWELL RX SCIENCES LLC	`b9f70d50fbb2637bdb7e9ea2349cfb70e0a8491697caadb279ae0b8df258a94b`
3753	N	050689	001	RIFABUTIN	CAPSULE;ORAL	CAPSULE	ORAL	MYCOBUTIN	PFIZER	150MG	AB	["AB"]	1992-12-23	Dec 23, 1992	No	Yes	Yes	RX	PFIZER INC	`847da3c5b47dc237f26d0611f777a2d1a799a7fc34178cd0cf0d41d700e4eb28`
3754	A	090253	001	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	CAPSULE	ORAL	MYCOPHENOLATE MOFETIL	ACCORD HLTHCARE	250MG	AB	["AB"]	2009-05-04	May 4, 2009	No	No	No	RX	ACCORD HEALTHCARE INC	`0a322e80db80f2a3357fad3e9ce16ca14e1c26a8683155c852b1c549f3cb6664`
3755	A	200197	001	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	CAPSULE	ORAL	MYCOPHENOLATE MOFETIL	ALKEM LABS LTD	250MG	AB	["AB"]	2013-06-13	Jun 13, 2013	No	No	No	RX	ALKEM LABORATORIES LTD	`e6a4aa8dac137d9e7c43477dd9717839c378a561ea97b32d5619e8fe572eafe4`
3756	A	090419	001	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	CAPSULE	ORAL	MYCOPHENOLATE MOFETIL	APOTEX CORP	250MG		[]	2009-04-22	Apr 22, 2009	No	No	No	DISCN	APOTEX CORP	`7fe935f7863e8f06e4b32f70c311aeef8f7fc392c7c4a2b3fe763161b81c9cc9`
3757	A	210181	001	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	CAPSULE	ORAL	MYCOPHENOLATE MOFETIL	CONCORD BIOTECH LTD	250MG	AB	["AB"]	2019-01-08	Jan 8, 2019	No	No	No	RX	CONCORD BIOTECH LTD	`3b870b2a246b97c31cb994acbe20e30bd84671585f6600e8f5d21403a2b275bc`
3758	A	091315	001	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	CAPSULE	ORAL	MYCOPHENOLATE MOFETIL	DR REDDYS LABS LTD	250MG		[]	2011-10-27	Oct 27, 2011	No	No	No	DISCN	DR REDDYS LABORATORIES LTD	`c5a6421826669ed90bd786d73cc77c028b23db11e33b4ee89ffe31be6306bccf`
3759	A	065410	001	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	CAPSULE	ORAL	MYCOPHENOLATE MOFETIL	HIKMA	250MG	AB	["AB"]	2008-07-29	Jul 29, 2008	No	No	No	RX	HIKMA PHARMACEUTICALS USA INC	`87f549c665d35911043a717672782967848f36db00c143f56532466d5f348271`
3760	A	090762	001	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	CAPSULE	ORAL	MYCOPHENOLATE MOFETIL	JUBILANT CADISTA	250MG		[]	2014-12-15	Dec 15, 2014	No	No	No	DISCN	JUBILANT CADISTA PHARMACEUTICALS INC	`75749e3c3eb91aedaba98f14f788c20ddb881459884274d6b0d9508b182d7733`
3761	A	065520	001	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	CAPSULE	ORAL	MYCOPHENOLATE MOFETIL	MYLAN	250MG	AB	["AB"]	2009-05-04	May 4, 2009	No	No	No	RX	MYLAN PHARMACEUTICALS INC	`b22da56ecf044f6f53940319e411822d6b7c88a8f10e6ecbb21a595704ae1903`
3762	A	065379	001	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	CAPSULE	ORAL	MYCOPHENOLATE MOFETIL	SANDOZ	250MG	AB	["AB"]	2008-10-15	Oct 15, 2008	No	No	No	RX	SANDOZ INC	`cbafb3bc3520d7da132f607cd8cd0bc3440582cf4c0799c1936a692d12fe7094`
3763	A	090055	001	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	CAPSULE	ORAL	MYCOPHENOLATE MOFETIL	STRIDES PHARMA	250MG	AB	["AB"]	2010-06-10	Jun 10, 2010	No	No	No	RX	STRIDES PHARMA GLOBAL PTE LTD	`df17da78e71ec6440090bb22fb80e824181aeeb110a4c543b3cf607a108b2447`
3764	A	065491	001	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	CAPSULE	ORAL	MYCOPHENOLATE MOFETIL	TEVA PHARMS	250MG	AB	["AB"]	2009-05-06	May 6, 2009	No	No	No	RX	TEVA PHARMACEUTICALS USA	`8e6b95fdabb5ec3dab4c116b526ec512e2a784835724969cc89cd7d92773d36d`
3765	A	090111	001	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	CAPSULE	ORAL	MYCOPHENOLATE MOFETIL	VINTAGE PHARMS LLC	250MG		[]	2009-12-22	Dec 22, 2009	No	No	No	DISCN	VINTAGE PHARMACEUTICALS LLC	`8aaf6a44aa971c2af48d96adba9c96f547a54a6b4b786735ec4dce6dd54944e2`
3766	A	204077	001	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	CAPSULE	ORAL	MYCOPHENOLATE MOFETIL	ZHEJIANG HISUN PHARM	250MG	AB	["AB"]	2017-11-13	Nov 13, 2017	No	No	No	RX	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	`b657e311ab61287b48ad2d0b67861607346f10911ffbb3c50c4fccce20c0b2b0`
3767	A	065433	001	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	CAPSULE	ORAL	MYCOPHENOLATE MOFETIL	ZYDUS PHARMS USA INC	250MG		[]	2009-05-04	May 4, 2009	No	No	No	DISCN	ZYDUS PHARMACEUTICALS USA INC	`f3c39642168692ea913ae2bd819afc9b45f2da940b84090220cda3d238e983d5`
3768	A	076485	001	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	MYORISAN	DOUGLAS PHARMS	10MG	AB1	["AB1"]	2012-01-19	Jan 19, 2012	No	No	No	RX	DOUGLAS PHARMACEUTICALS AMERICA LTD	`10179509c723ee5354cfcc9a55000971b1c61d8b2a344d50413229684d29508c`
3769	A	076485	002	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	MYORISAN	DOUGLAS PHARMS	20MG	AB1	["AB1"]	2012-01-19	Jan 19, 2012	No	No	No	RX	DOUGLAS PHARMACEUTICALS AMERICA LTD	`9992efdffc2578f4414230e1a9f59e0d2eabd2aa6b98bd63e3d10f5b00c29efd`
3770	A	076485	004	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	MYORISAN	DOUGLAS PHARMS	30MG	AB1	["AB1"]	2015-08-25	Aug 25, 2015	No	No	No	RX	DOUGLAS PHARMACEUTICALS AMERICA LTD	`0ec5cfbf2d912b965964dea025d9a5f427e55e33ccf6c942143a923e9d892570`
3771	A	076485	003	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	MYORISAN	DOUGLAS PHARMS	40MG	AB1	["AB1"]	2012-01-19	Jan 19, 2012	No	No	No	RX	DOUGLAS PHARMACEUTICALS AMERICA LTD	`480d9f3b6467dde3bf4fc7a6eec4bdf2d3aa33d7849cd2bf354ca0913b4bc5dd`
3772	N	017604	003	FENOPROFEN CALCIUM	CAPSULE;ORAL	CAPSULE	ORAL	NALFON	XSPIRE PHARMA	EQ 200MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	Yes	No	RX	XSPIRE PHARMA	`e782cb02fc7facd7037908768d3d1062b457c978e1e786bbb171488b47262106`
3773	N	017604	002	FENOPROFEN CALCIUM	CAPSULE;ORAL	CAPSULE	ORAL	NALFON	XSPIRE PHARMA	EQ 300MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	XSPIRE PHARMA	`1662711357b5f99698eb37aa13a91833a8d7f377f4eed4abc7017d98c5be943e`
3774	N	017604	004	FENOPROFEN CALCIUM	CAPSULE;ORAL	CAPSULE	ORAL	NALFON	XSPIRE PHARMA	EQ 400MG BASE		[]	2009-07-21	Jul 21, 2009	No	Yes	Yes	RX	XSPIRE PHARMA	`87e2596b1e37b7061ef252c6ac7660fc5720da8857ddbcf1e231d8a1442cb923`
3775	N	021920	001	NAPROXEN SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	NAPROXEN SODIUM	BIONPHARMA INC	EQ 200MG BASE		[]	2006-02-17	Feb 17, 2006	No	Yes	Yes	OTC	BIONPHARMA INC	`b9245b7074423176e9b8e5907b8be2a09ff153d588c7fbb39d262ff4cca08421`
3776	A	202807	001	NAPROXEN SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	NAPROXEN SODIUM	CATALENT	EQ 200MG BASE		[]	2019-01-04	Jan 4, 2019	No	No	No	OTC	CATALENT PHARMA SOLUTIONS LLC	`5287526b07c3821382eb69d0bb23abf9d89736c4e4d4054166b94f686dd90689`
3777	A	208363	001	NAPROXEN SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	NAPROXEN SODIUM	PURACAP PHARM LLC	EQ 200MG BASE		[]	2018-03-15	Mar 15, 2018	No	No	No	OTC	PURACAP PHARMACEUTICAL LLC	`3c72ddddc84ab2ad198665823cad3113519dff6234464829156a178a42e9002a`
3778	N	016584	001	THIOTHIXENE	CAPSULE;ORAL	CAPSULE	ORAL	NAVANE	PFIZER	1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]		Approved Prior to Jan 1, 1982	Yes	Yes	No	DISCN	PFIZER INC	`1ac878ad300e54277107d86b01f7839133a9b689161331da95caaf891e37e995`
3779	N	016584	002	THIOTHIXENE	CAPSULE;ORAL	CAPSULE	ORAL	NAVANE	PFIZER	2MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]		Approved Prior to Jan 1, 1982	Yes	Yes	No	DISCN	PFIZER INC	`60abeef8f3350ccd444e19139625604ae2703c7f1d90e032a144c1cd0b77d3cc`
3780	N	016584	003	THIOTHIXENE	CAPSULE;ORAL	CAPSULE	ORAL	NAVANE	PFIZER	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]		Approved Prior to Jan 1, 1982	Yes	Yes	No	DISCN	PFIZER INC	`803822fccbc365db6bebc8db8edf8732772e48daf06cc6789f34ac7246300097`
3781	N	016584	004	THIOTHIXENE	CAPSULE;ORAL	CAPSULE	ORAL	NAVANE	PFIZER	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]		Approved Prior to Jan 1, 1982	Yes	Yes	No	DISCN	PFIZER INC	`ff4e8938ec68c768026584d8e02e9e719a9dfe384b31d0b4763716f650d3446a`
3782	N	016584	005	THIOTHIXENE	CAPSULE;ORAL	CAPSULE	ORAL	NAVANE	PFIZER	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]		Approved Prior to Jan 1, 1982	Yes	Yes	No	DISCN	PFIZER INC	`4e60fdd4f2a1648a1cfb5f5126f70bd4219d24864ae665b4bc0e99222fd604f3`
3783	A	084095	001	PENTOBARBITAL SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	NEMBUTAL SODIUM	AKORN	30MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	AKORN OPERATING CO LLC	`2d88c478a2ad84dd5e1395b792364da926a4f383365aa06b36863d0d7061ad88`
3784	A	084093	001	PENTOBARBITAL SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	NEMBUTAL SODIUM	AKORN	50MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	AKORN OPERATING CO LLC	`725d2160f280d8d9539b04eeed043cb47912f0ab93ce612d347a27e2d202f24f`
3785	A	083245	001	PENTOBARBITAL SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	NEMBUTAL SODIUM	AKORN	100MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	AKORN OPERATING CO LLC	`18d55e1bfc0b90d6edf534ad9ddce69ef834ed113522afeea3fc06fe4c5f5626`
3786	N	050715	001	CYCLOSPORINE	CAPSULE;ORAL	CAPSULE	ORAL	NEORAL	NOVARTIS	25MG	AB1	["AB1"]	1995-07-14	Jul 14, 1995	No	Yes	No	RX	NOVARTIS PHARMACEUTICALS CORP	`2b199c48f1ecdbe9a99a3d92338ceaf5b0dd204392d56cb639424d020ac17468`
3787	N	050715	003	CYCLOSPORINE	CAPSULE;ORAL	CAPSULE	ORAL	NEORAL	NOVARTIS	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1995-07-14	Jul 14, 1995	No	Yes	No	DISCN	NOVARTIS PHARMACEUTICALS CORP	`a2e18824d5dfaca6cb3c755b469700284eebddd7b3e580f80a472c72304cdaa1`
3788	N	050715	002	CYCLOSPORINE	CAPSULE;ORAL	CAPSULE	ORAL	NEORAL	NOVARTIS	100MG	AB1	["AB1"]	1995-07-14	Jul 14, 1995	No	Yes	Yes	RX	NOVARTIS PHARMACEUTICALS CORP	`4e5a916bff4b473e0d20d40380bafa1e7dc82d9e7b486db44cae8c871b278d81`
3789	N	020235	001	GABAPENTIN	CAPSULE;ORAL	CAPSULE	ORAL	NEURONTIN	UPJOHN	100MG	AB	["AB"]	1993-12-30	Dec 30, 1993	No	Yes	No	RX	UPJOHN US 1 LLC	`a606dac5f19a5fa0676dda791a791731333f6667723e9d286257156b8242bbc9`
3790	N	020235	002	GABAPENTIN	CAPSULE;ORAL	CAPSULE	ORAL	NEURONTIN	UPJOHN	300MG	AB	["AB"]	1993-12-30	Dec 30, 1993	No	Yes	No	RX	UPJOHN US 1 LLC	`353d0d4d25ee051de843a8a09ed3044b40098a54ffdc69455e8cad2af222a34a`
3791	N	020235	003	GABAPENTIN	CAPSULE;ORAL	CAPSULE	ORAL	NEURONTIN	UPJOHN	400MG	AB	["AB"]	1993-12-30	Dec 30, 1993	No	Yes	Yes	RX	UPJOHN US 1 LLC	`11edcf87b1ec4a72263a715a3c6431583801050c10a0b7da40dd2f84d4a64180`
3792	A	074439	001	NICARDIPINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	NICARDIPINE HYDROCHLORIDE	ANI PHARMS INC	20MG		[]	1996-12-10	Dec 10, 1996	No	No	No	DISCN	ANI PHARMACEUTICALS INC	`8a251161c8b6f4ec8c8333bb5364a88ed45dda26494ed2969ed07d810f7064c1`
3793	A	074540	001	NICARDIPINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	NICARDIPINE HYDROCHLORIDE	ANI PHARMS INC	20MG		[]	1996-10-28	Oct 28, 1996	No	No	No	DISCN	ANI PHARMACEUTICALS INC	`898d27d4d551481fbedfc73aa72cb0a69ec71392c000b54aebba02bb197446e8`
3794	A	074670	001	NICARDIPINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	NICARDIPINE HYDROCHLORIDE	ANI PHARMS INC	20MG		[]	1996-10-28	Oct 28, 1996	No	No	No	DISCN	ANI PHARMACEUTICALS INC	`4f6a37ee8964a96ed24d51aaa98f48e5b41b6e1091702ebff4e0403e9313c502`
3795	A	074439	002	NICARDIPINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	NICARDIPINE HYDROCHLORIDE	ANI PHARMS INC	30MG		[]	1996-12-10	Dec 10, 1996	No	No	No	DISCN	ANI PHARMACEUTICALS INC	`962af6b4170632d9dbd407c22fd473fa149fb887fabcaafba343205f648fc0d4`
3796	A	074540	002	NICARDIPINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	NICARDIPINE HYDROCHLORIDE	ANI PHARMS INC	30MG		[]	1996-10-28	Oct 28, 1996	No	No	No	DISCN	ANI PHARMACEUTICALS INC	`6724f2e34f8ec01750fac066cfeb77ff0d36e53bea4839d804513feeeb76f60f`
3797	A	074670	002	NICARDIPINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	NICARDIPINE HYDROCHLORIDE	ANI PHARMS INC	30MG		[]	1996-10-28	Oct 28, 1996	No	No	No	DISCN	ANI PHARMACEUTICALS INC	`e12a5cd345f732a7aee74f5547a446bebc58e6ffedd4bf882dfb3fd7d0fb29f6`
3798	A	074928	001	NICARDIPINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	NICARDIPINE HYDROCHLORIDE	EPIC PHARMA	20MG		[]	1998-03-19	Mar 19, 1998	No	No	No	RX	EPIC PHARMA INC	`49e5a4b3eea60a195229b08f86af1a04ee1c7b87553fb4b68f0cd99ebde81632`
3799	A	074928	002	NICARDIPINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	NICARDIPINE HYDROCHLORIDE	EPIC PHARMA	30MG		[]	1998-03-19	Mar 19, 1998	No	No	Yes	RX	EPIC PHARMA INC	`d0be1cedb9a3ba4e59ccba4219f2cee04ce2b17d0e39a66935248c744430e241`
3800	A	074642	001	NICARDIPINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	NICARDIPINE HYDROCHLORIDE	MYLAN	20MG		[]	1996-07-18	Jul 18, 1996	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`353504bfd3ced8b4d520527ca3adae3bc63b7c8a5e3ed729b9ea2a09524b0744`
3801	A	074642	002	NICARDIPINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	NICARDIPINE HYDROCHLORIDE	MYLAN	30MG		[]	1996-07-18	Jul 18, 1996	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`c6a995c8faf66353f3667c840d00d6690d6ffac27801b9dd9484d9048b6c816b`