Orange Book snapshot 21: Products

Products page 49 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
2402	A	065044	001	CYCLOSPORINE	CAPSULE;ORAL	CAPSULE	ORAL	CYCLOSPORINE	MAYNE PHARMA	100MG	AB1	["AB1"]	2000-12-20	Dec 20, 2000	No	No	No	RX	MAYNE PHARMA LLC	`9d942e0dc37c611428f01f442b1c7b830bd408643d65adae012d2da6087d838e`
2403	A	065017	002	CYCLOSPORINE	CAPSULE;ORAL	CAPSULE	ORAL	CYCLOSPORINE	SANDOZ	25MG	AB1	["AB1"]	2000-01-13	Jan 13, 2000	No	No	No	RX	SANDOZ INC	`64a7394be220ad4d0895ae9898528b01a77998cd558165d99a07753e93d12163`
2404	A	065017	001	CYCLOSPORINE	CAPSULE;ORAL	CAPSULE	ORAL	CYCLOSPORINE	SANDOZ	100MG	AB1	["AB1"]	2000-01-13	Jan 13, 2000	No	No	No	RX	SANDOZ INC	`8bdce9fecdec0259a9d656e114e33efc2b5097fe8d084aa11571811c7c487a18`
2405	N	020392	001	CYSTEAMINE BITARTRATE	CAPSULE;ORAL	CAPSULE	ORAL	CYSTAGON	MYLAN	EQ 50MG BASE		[]	1994-08-15	Aug 15, 1994	No	Yes	No	RX	MYLAN PHARMACEUTICALS INC	`c2c7b88bdc6cdacb51f37de8a8b17622b9b2cf9c18eeb613dccbeacc84bc9d73`
2406	N	020392	002	CYSTEAMINE BITARTRATE	CAPSULE;ORAL	CAPSULE	ORAL	CYSTAGON	MYLAN	EQ 150MG BASE		[]	1994-08-15	Aug 15, 1994	No	Yes	Yes	RX	MYLAN PHARMACEUTICALS INC	`41f625f38639c2e1c3538f4c4e64fa6ca2a7ac3abc5d4bd29ad8f6a79a0562d1`
2407	N	020460	001	GANCICLOVIR	CAPSULE;ORAL	CAPSULE	ORAL	CYTOVENE	ROCHE PALO	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1994-12-22	Dec 22, 1994	No	Yes	No	DISCN	ROCHE PALO ALTO LLC	`852df5d61b429ea7ec1f5e0cda8d0ce92733ae296c754a37a354801bf21d36aa`
2408	N	020460	002	GANCICLOVIR	CAPSULE;ORAL	CAPSULE	ORAL	CYTOVENE	ROCHE PALO	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1997-12-12	Dec 12, 1997	No	Yes	No	DISCN	ROCHE PALO ALTO LLC	`24b9a564b06b7e0f0451822383ed5bb443e68fed6b310c0cd864de26e11c2569`
2409	A	208040	001	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	CAPSULE	ORAL	DABIGATRAN ETEXILATE MESYLATE	ALKEM LABS LTD	EQ 75MG BASE	AB	["AB"]	2020-03-11	Mar 11, 2020	No	No	No	RX	ALKEM LABORATORIES LTD	`02ebf13e2d3654aecd0bd81af690a312efc1c8eceb2fbdab1663e3729d02bbfc`
2410	A	208040	002	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	CAPSULE	ORAL	DABIGATRAN ETEXILATE MESYLATE	ALKEM LABS LTD	EQ 150MG BASE	AB	["AB"]	2020-03-11	Mar 11, 2020	No	No	No	RX	ALKEM LABORATORIES LTD	`eb69d533b9723a03204216eec2d069bacf5d53e124eeed5262dad3ae3b3e1039`
2411	A	207961	001	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	CAPSULE	ORAL	DABIGATRAN ETEXILATE MESYLATE	HETERO LABS LTD III	EQ 75MG BASE	AB	["AB"]	2020-05-06	May 6, 2020	No	No	No	RX	HETERO LABS LTD UNIT III	`19cbed58ada0537668532225f84aaa468dd90f108d3f626ad093ed89a50755de`
2412	A	207961	002	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	CAPSULE	ORAL	DABIGATRAN ETEXILATE MESYLATE	HETERO LABS LTD III	EQ 150MG BASE	AB	["AB"]	2020-05-06	May 6, 2020	No	No	No	RX	HETERO LABS LTD UNIT III	`4db9f4529a33c3a19befbf6d2385dec498eabad768db466ca112e6a3247020d3`
2413	N	016721	001	FLURAZEPAM HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	DALMANE	VALEANT PHARM INTL	15MG 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	VALEANT PHARMACEUTICALS INTERNATIONAL	`78066ea7bf53a340bd881366d5e15b19c56592bcbb53fa32db683ae8cd2fe1e9`
2414	N	016721	002	FLURAZEPAM HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	DALMANE	VALEANT PHARM INTL	30MG 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	VALEANT PHARMACEUTICALS INTERNATIONAL	`f9062324386a4754b201e234d9cd529ee22702c093b1408b80e3f18c836490f0`
2415	A	071569	001	DANAZOL	CAPSULE;ORAL	CAPSULE	ORAL	DANAZOL	AM THERAP	200MG		[]	1987-12-30	Dec 30, 1987	No	No	No	DISCN	AMERICAN THERAPEUTICS INC	`1baa94ead65b2c4964f7fab8a8d8c12d0c520d9c576b71b95562906a9573db20`
2416	A	074582	003	DANAZOL	CAPSULE;ORAL	CAPSULE	ORAL	DANAZOL	BARR	50MG	AB	["AB"]	1998-05-29	May 29, 1998	No	No	No	RX	BARR LABORATORIES INC	`69c6df571fd522d5f7c159ae8c92ab168f40a3619d058dbf318c4d77bd8da66c`
2417	A	074582	002	DANAZOL	CAPSULE;ORAL	CAPSULE	ORAL	DANAZOL	BARR	100MG	AB	["AB"]	1998-05-29	May 29, 1998	No	No	No	RX	BARR LABORATORIES INC	`3579e2ffc924eebe41a797f2021996e5a7032eda850a3917a73852236cf99d19`
2418	A	074582	001	DANAZOL	CAPSULE;ORAL	CAPSULE	ORAL	DANAZOL	BARR	200MG	AB	["AB"]	1996-08-09	Aug 9, 1996	No	No	Yes	RX	BARR LABORATORIES INC	`2dd18f8b61d35f1266e19730eb2f66f71f9237c9bb1d10a575aff925a2d5e1d9`
2419	A	077246	002	DANAZOL	CAPSULE;ORAL	CAPSULE	ORAL	DANAZOL	LANNETT CO INC	50MG	AB	["AB"]	2007-04-19	Apr 19, 2007	No	No	No	RX	LANNETT CO INC	`5d7b16a23b8bc3a99b773a9f3c16b66ffb17d6040bc2ee74529269e00e1c73b9`
2420	A	077246	003	DANAZOL	CAPSULE;ORAL	CAPSULE	ORAL	DANAZOL	LANNETT CO INC	100MG	AB	["AB"]	2007-04-19	Apr 19, 2007	No	No	No	RX	LANNETT CO INC	`a619b0b51b6e4e18305de0f652fd7b3db362aee8acf260f4f191dfa1fde6a68c`
2421	A	077246	001	DANAZOL	CAPSULE;ORAL	CAPSULE	ORAL	DANAZOL	LANNETT CO INC	200MG	AB	["AB"]	2005-09-28	Sep 28, 2005	No	No	No	RX	LANNETT CO INC	`81e1c3acd7a15c9c310352d2c3fff8985b7c17d2ae8f46eb7c6845476a39e056`
2422	N	017557	003	DANAZOL	CAPSULE;ORAL	CAPSULE	ORAL	DANOCRINE	SANOFI AVENTIS US	50MG 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	SANOFI AVENTIS US LLC	`3785ac2faa51a5c4a60fa555aa4aae1e77635c9c02b558a4f585bbb4a4deb254`
2423	N	017557	004	DANAZOL	CAPSULE;ORAL	CAPSULE	ORAL	DANOCRINE	SANOFI AVENTIS US	100MG 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	SANOFI AVENTIS US LLC	`dedeee52801b8471aa04a77a5773c8a1e5a75bdaf7611784553c21a9a1c5f48a`
2424	N	017557	002	DANAZOL	CAPSULE;ORAL	CAPSULE	ORAL	DANOCRINE	SANOFI AVENTIS US	200MG 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	SANOFI AVENTIS US LLC	`b15697ee72a0d6dab39837eb8903fc999507f3995c310fd887f0daaa3fd03cf2`
2425	N	017443	001	DANTROLENE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	DANTRIUM	PAR STERILE PRODUCTS	25MG	AB	["AB"]		Approved Prior to Jan 1, 1982	Yes	Yes	No	RX	PAR STERILE PRODUCTS LLC	`2f9c6f2fd5fcf847040242e9ba27752455e01a70d3537880c6e4ddaf678418f0`
2426	N	017443	003	DANTROLENE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	DANTRIUM	PAR STERILE PRODUCTS	50MG	AB	["AB"]		Approved Prior to Jan 1, 1982	Yes	Yes	No	RX	PAR STERILE PRODUCTS LLC	`872312290c3a63a6e6fedda5fc529f1f9acfc58f576d3a6236d3819a11c19ea0`
2427	N	017443	002	DANTROLENE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	DANTRIUM	PAR STERILE PRODUCTS	100MG	AB	["AB"]		Approved Prior to Jan 1, 1982	Yes	Yes	Yes	RX	PAR STERILE PRODUCTS LLC	`5f2c5843bcce3d8697c6548341ff5d9f8cf116dd8bbe81e246be0c4e518d7158`
2428	A	076686	001	DANTROLENE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	DANTROLENE SODIUM	ELITE LABS INC	25MG	AB	["AB"]	2005-10-24	Oct 24, 2005	No	No	No	RX	ELITE LABORATORIES INC	`bce2cefd174a5aaa9f2e9a1a7eb7d2a9e81167e5bb719ff16a87c1634a2d1cca`
2429	A	076686	002	DANTROLENE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	DANTROLENE SODIUM	ELITE LABS INC	50MG	AB	["AB"]	2005-10-24	Oct 24, 2005	No	No	No	RX	ELITE LABORATORIES INC	`59f09901140f811e51116cdff173e6cf633ed8d4e1962bc9aec10eb05bf900a8`
2430	A	076686	003	DANTROLENE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	DANTROLENE SODIUM	ELITE LABS INC	100MG	AB	["AB"]	2005-10-24	Oct 24, 2005	No	No	No	RX	ELITE LABORATORIES INC	`4065f7b98de6af4888e5ee96a2f84c2ec8b6b839aac63a018100e8f336b6527a`
2431	A	076856	001	DANTROLENE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	DANTROLENE SODIUM	IMPAX LABS	25MG	AB	["AB"]	2005-03-01	Mar 1, 2005	No	No	No	RX	IMPAX LABORATORIES INC	`1e111e02b40c974e5ab7dc92cc52ba3aff154a4ab3d9a51ee937d3db0add9ebc`
2432	A	076856	002	DANTROLENE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	DANTROLENE SODIUM	IMPAX LABS	50MG	AB	["AB"]	2005-03-01	Mar 1, 2005	No	No	No	RX	IMPAX LABORATORIES INC	`5fe72395568ffe3fe83c47071f2727b9bcb74a200e2f313d0ae56567750b6640`
2433	A	076856	003	DANTROLENE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	DANTROLENE SODIUM	IMPAX LABS	100MG	AB	["AB"]	2005-03-01	Mar 1, 2005	No	No	No	RX	IMPAX LABORATORIES INC	`6b956d5e186c423360407e91760c7c1e0db7cee2b2ef96b41ac57cd12e43fd6f`
2434	N	010997	001	PROPOXYPHENE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	DARVON	XANODYNE PHARM	32MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	XANODYNE PHARMACEUTICS INC	`2763848bb3fc3685a165f83aa3f40a516635b0c18319d72794e83eb3424114cb`
2435	N	010997	003	PROPOXYPHENE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	DARVON	XANODYNE PHARM	65MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	XANODYNE PHARMACEUTICS INC	`10944f9c850cd0e7bdf978503763cbf0bc604dc1e59648b66fedcbea9f0c77d9`
2436	N	010996	006	ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	DARVON COMPOUND	XANODYNE PHARM	389MG;32.4MG;32MG		[]	1983-03-08	Mar 8, 1983	No	No	No	DISCN	XANODYNE PHARMACEUTICS INC	`91dfd0a15206cb86975ce0dbf6eb8f4a0f238ddae7868c79638bfe41bfb52c24`
2437	N	010996	007	ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	DARVON COMPOUND-65	XANODYNE PHARM	389MG;32.4MG;65MG		[]	1983-03-08	Mar 8, 1983	No	No	No	DISCN	XANODYNE PHARMACEUTICS INC	`1ee673b64eb4880f7a7e6d73a78bbac93f59c794aeec8a20cece1065088da2b6`
2438	N	010996	005	ASPIRIN; PROPOXYPHENE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	DARVON W/ ASA	XANODYNE PHARM	325MG;65MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	XANODYNE PHARMACEUTICS INC	`61aa086a6de2f0cca43b3a6d701ea3fac9a15846835ddca8047c14a6c880d5eb`
2439	N	016829	001	ASPIRIN; PROPOXYPHENE NAPSYLATE	CAPSULE;ORAL	CAPSULE	ORAL	DARVON-N W/ ASA	AAIPHARMA LLC	325MG;100MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	AAIPHARMA LLC	`669a0b562002af09b85a6e4c45ae33a4448a455caa697ab2e3f9d7fa201d4c43`
2440	N	050262	001	DEMECLOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	DECLOMYCIN	LEDERLE	150MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO	`d3da8a8cc0c4e3a77f264a9a28692a6bd949014fac24baa30975a5592f2cacf6`
2441	A	080830	001	VITAMIN A PALMITATE	CAPSULE;ORAL	CAPSULE	ORAL	DEL-VI-A	DEL RAY LABS	EQ 50,000 UNITS BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	DEL RAY LABORATORIES INC	`e6f67e05e5dff3ef2ffa7ba1acd5158555132c660c96a3c17194a9fd24c2b0b7`
2442	A	083564	001	AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE	CAPSULE;ORAL	CAPSULE	ORAL	DELCOBESE	TEVA	1.25MG;1.25MG;1.25MG;1.25MG 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	TEVA PHARMACEUTICALS USA INC	`61f5aa20ff2085400f9c784eb935b4ae652d71b778117bd2be62dd8c9e023866`
2443	A	083564	002	AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE	CAPSULE;ORAL	CAPSULE	ORAL	DELCOBESE	TEVA	2.5MG;2.5MG;2.5MG;2.5MG 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	TEVA PHARMACEUTICALS USA INC	`59162584d94afa1f8441c88a888f7d4fff282af5d7edf3c729716431aeff3d8b`
2444	A	083564	003	AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE	CAPSULE;ORAL	CAPSULE	ORAL	DELCOBESE	TEVA	3.75MG;3.75MG;3.75MG;3.75MG 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	TEVA PHARMACEUTICALS USA INC	`098822c053dcbd13ad1856735a8620aaf04b71e401ab2d0db32b51cc062aacd5`
2445	A	083564	004	AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE	CAPSULE;ORAL	CAPSULE	ORAL	DELCOBESE	TEVA	5MG;5MG;5MG;5MG 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	TEVA PHARMACEUTICALS USA INC	`834b35def7ad690fe55530c281695c22567d9b15551b4fcb1cd6c406abf63226`
2446	A	080884	001	ERGOCALCIFEROL	CAPSULE;ORAL	CAPSULE	ORAL	DELTALIN	LILLY	50,000 IU		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	ELI LILLY AND CO	`e566642539e502f65b1d36dd6e618bde5eade6e8cd58586b2e9e2def1e0e7df0`
2447	N	017871	001	METYROSINE	CAPSULE;ORAL	CAPSULE	ORAL	DEMSER	BAUSCH	250MG	AB	["AB"]		Approved Prior to Jan 1, 1982	Yes	Yes	Yes	RX	BAUSCH HEALTH US LLC	`7450aa7d9d30fb9ea0ee212d0f2d42298d941259b9df15d967e508a2396cfc45`
2448	N	018081	001	VALPROIC ACID	CAPSULE;ORAL	CAPSULE	ORAL	DEPAKENE	ABBVIE	250MG		[]		Approved Prior to Jan 1, 1982	Yes	Yes	No	DISCN	ABBVIE INC	`df9da7166c849a275938364420a589b5b1839ad732b9d342ae8c348c05db577a`
2449	A	085355	001	DEXTROAMPHETAMINE SULFATE	CAPSULE;ORAL	CAPSULE	ORAL	DEXAMPEX	TEVA	15MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	TEVA PHARMACEUTICALS USA INC	`85122a0f4c65411352a738b3ad673b36ef8e4abbbbb2dfcd82a016343a362827`
2450	A	202934	001	DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE	CAPSULE;ORAL	CAPSULE	ORAL	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	ACTAVIS ELIZABETH	20MG;10MG	AB	["AB"]	2017-10-10	Oct 10, 2017	No	No	No	RX	ACTAVIS ELIZABETH LLC	`6240ee81544f746b4f9bbbb39dc103dc7442d016ebf1c4a4870662491bc27197`
2451	A	088584	001	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE	CAPSULE;ORAL	CAPSULE	ORAL	DHC PLUS	PHARM RES ASSOC	356.4MG;30MG;16MG		[]	1986-03-04	Mar 4, 1986	No	No	No	DISCN	PHARMACEUTICAL RESEARCH ASSOC INC	`06dbc13333471f1c8fbafc8529e66f13bd7d6d58e12493cde2c3a08a1f6413e9`