Orange Book snapshot 21: Products

Products page 77 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
3802	A	072781	001	NIFEDIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIFEDIPINE	ACELLA	10MG	AB	["AB"]	1993-07-30	Jul 30, 1993	No	No	No	RX	ACELLA PHARMACEUTICALS LLC	`f4d6e81a00844b3aaac802522116457420030ce54bc14076deaf9e473bb943d9`
3803	A	072579	001	NIFEDIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIFEDIPINE	ACTAVIS ELIZABETH	10MG	AB	["AB"]	1991-01-08	Jan 8, 1991	No	No	No	RX	ACTAVIS ELIZABETH LLC	`4123b5eb7e8a2655b78b9c5a79f1c1070ae6dcb9c387f353aaa81a3c8ce345c4`
3804	A	072556	001	NIFEDIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIFEDIPINE	ACTAVIS ELIZABETH	20MG	AB	["AB"]	1990-09-20	Sep 20, 1990	No	No	No	RX	ACTAVIS ELIZABETH LLC	`e902301cf3805d7eb1c44f3bd7ddb01c52e2b2f2d9dbb0ab84655aa3a72b716b`
3805	A	072409	001	NIFEDIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIFEDIPINE	CHASE LABS NJ	10MG		[]	1990-07-04	Jul 4, 1990	No	No	No	DISCN	CHASE LABORATORIES INC	`318749e572d3856266002bb681e41a0c7931142d4ccd18fca3c99d26c11d2ee4`
3806	A	073421	001	NIFEDIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIFEDIPINE	CHASE LABS NJ	20MG		[]	1991-06-19	Jun 19, 1991	No	No	No	DISCN	CHASE LABORATORIES INC	`ee32ce2699bddb38756c366374a9e59b5f5a6062240599723ea511bfd9b63b90`
3807	A	202644	001	NIFEDIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIFEDIPINE	HERITAGE PHARMA	10MG	AB	["AB"]	2013-04-25	Apr 25, 2013	No	No	No	RX	HERITAGE PHARMA LABS INC	`0283dabaeee20f07497539c3f0ff25307724337fa48b892bf0a80b8cabddf4cb`
3808	A	202644	002	NIFEDIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIFEDIPINE	HERITAGE PHARMA	20MG	AB	["AB"]	2013-04-25	Apr 25, 2013	No	No	No	RX	HERITAGE PHARMA LABS INC	`d5725247f224a728ab439f8dc8723caab758e07af791a1ae63713fb2bc812b6c`
3809	A	073250	001	NIFEDIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIFEDIPINE	LEADING PHARMA LLC	10MG	AB	["AB"]	1991-10-08	Oct 8, 1991	No	No	No	RX	LEADING PHARMA LLC	`4bb23a815a95fa346596324189984077febc46a9319fe71c65deeb04fd606e6a`
3810	A	074045	001	NIFEDIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIFEDIPINE	LEADING PHARMA LLC	20MG	AB	["AB"]	1992-04-30	Apr 30, 1992	No	No	No	RX	LEADING PHARMA LLC	`054f5683aa6351e184e115cd8e6f374212e05bfc42d7c6c110196506506ccbb3`
3811	A	072651	001	NIFEDIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIFEDIPINE	TEVA	10MG		[]	1992-02-19	Feb 19, 1992	No	No	No	DISCN	TEVA PHARMACEUTICALS USA INC	`cd99e3abe87c8c78a04e31be6c7224f6dc27ea790fc25813a289fbafa0016535`
3812	A	076740	001	NIMODIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIMODIPINE	BIONPHARMA INC	30MG	AB	["AB"]	2008-01-17	Jan 17, 2008	No	No	Yes	RX	BIONPHARMA INC	`b5cdf7c4abf53a32414e6a1e5e8ae550ee71e802ef1490e0ae9472f5a00013db`
3813	A	077811	001	NIMODIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIMODIPINE	HERITAGE PHARMS INC	30MG	AB	["AB"]	2007-05-02	May 2, 2007	No	No	No	RX	HERITAGE PHARMACEUTICALS INC	`5bc8bf4229e502775c986555637d7a1b50f6c7725c31ac995f7dffdd9b58afb2`
3814	A	201832	001	NIMODIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIMODIPINE	SOFGEN PHARMS	30MG	AB	["AB"]	2015-07-24	Jul 24, 2015	No	No	No	RX	SOFGEN PHARMACEUTICALS	`f5c558db265e4dc4186d5d2c3f6b3dc2dbd93365a1efc30a6d302b352ad135d0`
3815	A	077067	001	NIMODIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIMODIPINE	SUN PHARM INDS INC	30MG		[]	2007-04-17	Apr 17, 2007	No	No	No	DISCN	SUN PHARMACEUTICAL INDUSTRIES INC	`22ca92a9e4c867818f04637f08a5ab8812b76086a82b8f86baed92b6467a4a2a`
3816	A	090103	001	NIMODIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIMODIPINE	THEPHARMANETWORK LLC	30MG	AB	["AB"]	2014-04-07	Apr 7, 2014	No	No	No	RX	THEPHARMANETWORK LLC	`a6a1f401ca7817e92ecf051daee83371f9d88977d81b5ee31a64357e569e325f`
3817	N	018869	001	NIMODIPINE	CAPSULE;ORAL	CAPSULE	ORAL	NIMOTOP	BAYER PHARMS	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1988-12-28	Dec 28, 1988	No	Yes	No	DISCN	BAYER PHARMACEUTICALS CORP	`ca8b178b68d66d3b16e3b1e3969a077a750c4ea63e65cab3ee67e9a151fbeaee`
3818	N	208462	001	IXAZOMIB CITRATE	CAPSULE;ORAL	CAPSULE	ORAL	NINLARO	MILLENNIUM PHARMS	EQ 2.3MG BASE		[]	2015-11-20	Nov 20, 2015	No	Yes	No	RX	MILLENNIUM PHARMACEUTICALS INC	`be426e148741d245c8f4772e81d7bfaa1d2d57bca179c0b1c8908f2048c6de56`
3819	N	208462	002	IXAZOMIB CITRATE	CAPSULE;ORAL	CAPSULE	ORAL	NINLARO	MILLENNIUM PHARMS	EQ 3MG BASE		[]	2015-11-20	Nov 20, 2015	No	Yes	No	RX	MILLENNIUM PHARMACEUTICALS INC	`23ba768f8698f475152457923f0808e72fa8ef28928e7eafbdb4d21099a1a5ec`
3820	N	208462	003	IXAZOMIB CITRATE	CAPSULE;ORAL	CAPSULE	ORAL	NINLARO	MILLENNIUM PHARMS	EQ 4MG BASE		[]	2015-11-20	Nov 20, 2015	No	Yes	Yes	RX	MILLENNIUM PHARMACEUTICALS INC	`87de03c1256606082e4378756222e06c3421761a6caf1eabab0241a910f225cf`
3821	A	211041	001	NITISINONE	CAPSULE;ORAL	CAPSULE	ORAL	NITISINONE	NOVITIUM PHARMA	2MG	AB	["AB"]	2019-08-26	Aug 26, 2019	No	No	No	RX	NOVITIUM PHARMA LLC	`242144bce7813b4c1fb86235b7e3cde918ed6d0f0f39e8539367d41302533c52`
3822	A	211041	002	NITISINONE	CAPSULE;ORAL	CAPSULE	ORAL	NITISINONE	NOVITIUM PHARMA	5MG	AB	["AB"]	2019-08-26	Aug 26, 2019	No	No	No	RX	NOVITIUM PHARMA LLC	`2c3544fe8ed4f2b98861624b894944187aa5150ac0a0adc2b23846efaddc0ce4`
3823	A	211041	003	NITISINONE	CAPSULE;ORAL	CAPSULE	ORAL	NITISINONE	NOVITIUM PHARMA	10MG	AB	["AB"]	2019-08-26	Aug 26, 2019	No	No	No	RX	NOVITIUM PHARMA LLC	`3da48bd4f4db451979349f18a14806f7a13bc198708055e1ff6d8c3731c9ac54`
3824	A	091095	001	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	ACTAVIS LABS FL INC	25MG	AB	["AB"]	2015-06-18	Jun 18, 2015	No	No	No	RX	ACTAVIS LABORATORIES FL INC	`398d6970be0ce84ac42eee7734b987ab9d82390286a161813d13f15bc959eed3`
3825	A	091095	002	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	ACTAVIS LABS FL INC	50MG	AB	["AB"]	2015-06-18	Jun 18, 2015	No	No	No	RX	ACTAVIS LABORATORIES FL INC	`56bb57cdfe8ae23d26aa7b54fae128df2952331dae88ceddceb3189acdf9274c`
3826	A	091095	003	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	ACTAVIS LABS FL INC	100MG	AB	["AB"]	2015-06-18	Jun 18, 2015	No	No	No	RX	ACTAVIS LABORATORIES FL INC	`c0bc32353c556ac9daa262d7a8148372579e38d3d7ab3d709cc82d756d58e848`
3827	A	073671	001	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	IMPAX LABS INC	50MG	AB	["AB"]	1993-01-28	Jan 28, 1993	No	No	No	RX	IMPAX LABORATORIES INC	`1b61ba2cea90eeb4611bade2f48dd53b3944d9795818b3ab44145ac63541ee27`
3828	A	073652	001	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	IMPAX LABS INC	100MG	AB	["AB"]	1993-01-28	Jan 28, 1993	No	No	No	RX	IMPAX LABORATORIES INC	`66d754719b8e61775e52559a3b6e13cc05735cfc3447ecaa57efcd970e9230d4`
3829	A	074967	001	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	MYLAN	50MG		[]	1997-07-09	Jul 9, 1997	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`3d404a640c6b26d2cac056d41063c5c13ecdae1bbb3d71bb3eb0231789898b2a`
3830	A	074967	002	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	MYLAN	100MG		[]	1997-07-09	Jul 9, 1997	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`b0a7eb1f9051fda54a28b2aaea2d381cee762474d82aaef8a83186c726eee863`
3831	A	077025	001	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	MYLAN	100MG		[]	2004-08-18	Aug 18, 2004	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`c7a68370e1b07ede3efae8987f1e6ac855ac05fd68ee58aade893d651f839362`
3832	A	203233	001	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	NOVEL LABS INC	50MG	AB	["AB"]	2018-07-09	Jul 9, 2018	No	No	No	RX	NOVEL LABORATORIES INC	`237cddb21172c979718654eaf56d26db8cd41a40d82fa9743e557c49af8b57ed`
3833	A	203233	002	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	NOVEL LABS INC	100MG	AB	["AB"]	2018-07-09	Jul 9, 2018	No	No	No	RX	NOVEL LABORATORIES INC	`2c2244195ec12b25b63296274b9cc9e2549a844a49202204ac493b1695a1e388`
3834	A	074336	001	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	PHARMGEN	25MG		[]	1995-01-25	Jan 25, 1995	No	No	No	DISCN	PHARMGEN LLC	`24191206cf748ad75de4b8b96cafd3067fd4b8761fce315e44f8622f9f0dc9c4`
3835	A	074336	002	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	PHARMGEN	50MG		[]	1995-01-25	Jan 25, 1995	No	No	No	DISCN	PHARMGEN LLC	`b18ddff98cc8513cb3255e9fdec28107ba4353a28fa26de3fde102ad3f78bfe3`
3836	A	074336	003	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	PHARMGEN	100MG		[]	1995-01-25	Jan 25, 1995	No	No	No	DISCN	PHARMGEN LLC	`9dea6e2923459f6886fcf4f595c93803856d8c459ff5d626a9d7e1340f98c92b`
3837	A	201722	001	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	SUN PHARM INDUSTRIES	25MG	AB	["AB"]	2016-02-16	Feb 16, 2016	No	No	No	RX	SUN PHARMACEUTICAL INDUSTRIES INC	`0ba8a67cada2b81f0b0d7687d6c16b37de160727d3e9fee4497a268532360172`
3838	A	201722	002	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	SUN PHARM INDUSTRIES	50MG	AB	["AB"]	2016-02-16	Feb 16, 2016	No	No	No	RX	SUN PHARMACEUTICAL INDUSTRIES INC	`2bc448b1a7afb67b0c6dcdd5df67bc0f6b6841d0ceb37a98d4dbd8cbc5f2d49a`
3839	A	201722	003	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	SUN PHARM INDUSTRIES	100MG	AB	["AB"]	2016-02-16	Feb 16, 2016	No	No	No	RX	SUN PHARMACEUTICAL INDUSTRIES INC	`d7b33ce44bc4a2f6baf9154123f206ff32478bf16098b2608cb6470a2b28be6b`
3840	A	073696	001	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	WATSON LABS	25MG		[]	1992-12-31	Dec 31, 1992	No	No	No	DISCN	WATSON LABORATORIES INC	`3dec86d741789fbdcb40f0456796bae83f5ab9e75d75e26a1ea6ae6f8acbfd2a`
3841	A	073696	002	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	WATSON LABS	50MG		[]	1992-12-31	Dec 31, 1992	No	No	No	DISCN	WATSON LABORATORIES INC	`2a4fe1ad2328d87b3b463d927a727c1981871bb3c3b4fd59019721693121b810`
3842	A	084326	001	NITROFURANTOIN	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	WATSON LABS	50MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	WATSON LABORATORIES INC	`e1e7ebedee12d0999ef355c4562992af51eedf44642acfcbe93bccae1ff6db71`
3843	A	073696	003	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	WATSON LABS	100MG		[]	1992-12-31	Dec 31, 1992	No	No	No	DISCN	WATSON LABORATORIES INC	`3e7c7820dca09337f19060d5fcdbc5ff0cde4f77ec78fb9354ce20e6d4b08cfc`
3844	A	084326	002	NITROFURANTOIN	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	WATSON LABS	100MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	WATSON LABORATORIES INC	`79fd76497c8c4874e69bd9912c8956793b62d50f9a5b2e5e063af60e388554cf`
3845	A	205005	001	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	ZYDUS PHARMS	50MG	AB	["AB"]	2017-12-12	Dec 12, 2017	No	No	No	RX	ZYDUS PHARMACEUTICALS USA INC	`dd10b03dcf94eddb3da42bfe9fd0723415550bef76ea938ec261eb3888a86d25`
3846	A	205005	002	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN	ZYDUS PHARMS	100MG	AB	["AB"]	2017-12-12	Dec 12, 2017	No	No	No	RX	ZYDUS PHARMACEUTICALS USA INC	`8d86b2a907811811ce7f237d3e10a1fce772585ef1c104fc195ad02dfc2c2b00`
3847	A	207372	001	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	AMNEAL PHARMS	75MG;25MG	AB	["AB"]	2017-05-15	May 15, 2017	No	No	No	RX	AMNEAL PHARMACEUTICALS	`81b376155ddc08cd34bff295618b41f9eed2ac1cfe2e034cdc5be76b819ae934`
3848	A	076648	001	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	MYLAN	75MG;25MG	AB	["AB"]	2004-03-22	Mar 22, 2004	No	No	No	RX	MYLAN PHARMACEUTICALS INC	`3b1813fa0d4a7e078a204d7e3c3b24f16cd6be57ddba2c4198f87a15f7bae083`
3849	A	076951	001	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	RANBAXY LABS LTD	75MG;25MG		[]	2005-03-30	Mar 30, 2005	No	No	No	DISCN	RANBAXY LABORATORIES LTD	`1112fa4fc79201f51704397496750984c97f3730fa06e90a17f2cccc352e08ba`
3850	A	077066	001	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	SANDOZ	75MG;25MG	AB	["AB"]	2005-04-05	Apr 5, 2005	No	No	No	RX	SANDOZ INC	`4c07f4c427310b71389988e4790914fafd4845933be9fd49bb790f206989030f`
3851	A	208516	001	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	CAPSULE	ORAL	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	SUNNY PHARMTECH INC	75MG;25MG	AB	["AB"]	2018-05-24	May 24, 2018	No	No	No	RX	SUNNY PHARMTECH INC	`7043487c6ca6a736b28186ad291d1fe28d3edef569b2c18fb9798a2654b31abd`