Orange Book snapshot 21: Products

Products page 71 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
3502	A	074014	003	KETOPROFEN	CAPSULE;ORAL	CAPSULE	ORAL	KETOPROFEN	HERITAGE PHARMS INC	75MG	AB	["AB"]	1993-01-29	Jan 29, 1993	No	No	No	RX	HERITAGE PHARMACEUTICALS INC	`b4d54a2274a977a46759d94c071e429b8f3c46ad7db689c286ca4d1439d28267`
3503	A	074035	002	KETOPROFEN	CAPSULE;ORAL	CAPSULE	ORAL	KETOPROFEN	MYLAN	50MG		[]	1996-12-31	Dec 31, 1996	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`fa9747b19ac6bdd9a65e9bb4f757f9d51f2e0a5e2a47d1d0502b9276cd191fe6`
3504	A	074035	003	KETOPROFEN	CAPSULE;ORAL	CAPSULE	ORAL	KETOPROFEN	MYLAN	75MG		[]	1996-12-31	Dec 31, 1996	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`c6b3522ff2d1a38893fed23ccdca336ce033be512d820c0b8e8b5a7c610565a7`
3505	A	074024	001	KETOPROFEN	CAPSULE;ORAL	CAPSULE	ORAL	KETOPROFEN	RISING	50MG		[]	1995-12-29	Dec 29, 1995	No	No	No	DISCN	RISING PHARMA HOLDINGS INC	`4abb50a14ff0bfc11a9751e9d5cc076f3a7031a091524b8986137bf5a508ea0e`
3506	A	074024	002	KETOPROFEN	CAPSULE;ORAL	CAPSULE	ORAL	KETOPROFEN	RISING	75MG		[]	1995-12-29	Dec 29, 1995	No	No	No	DISCN	RISING PHARMA HOLDINGS INC	`dcfd563e5edcb903cb99f8a98338d209a1c53f4bc710bbe59011debd3a1fc6ae`
3507	A	073515	001	KETOPROFEN	CAPSULE;ORAL	CAPSULE	ORAL	KETOPROFEN	TEVA	25MG		[]	1992-12-22	Dec 22, 1992	No	No	No	DISCN	TEVA PHARMACEUTICALS USA INC	`e0831a11f57aa05f298e013ce2d6c3db797b24e05846a662b53193ed80c81630`
3508	A	073516	001	KETOPROFEN	CAPSULE;ORAL	CAPSULE	ORAL	KETOPROFEN	TEVA	50MG	AB	["AB"]	1992-12-22	Dec 22, 1992	No	No	No	RX	TEVA PHARMACEUTICALS USA INC	`4aa0d39c1b1bbeb3f9e107479e039ca4b9a276828deb649d76a6dcf8a621dcd1`
3509	A	073517	001	KETOPROFEN	CAPSULE;ORAL	CAPSULE	ORAL	KETOPROFEN	TEVA	75MG	AB	["AB"]	1992-12-22	Dec 22, 1992	No	No	Yes	RX	TEVA PHARMACEUTICALS USA INC	`7e66879a90783312402cd7b24818ecc61905b38a82c0f46bdab5971aad83ac2c`
3510	N	213756	001	SELUMETINIB SULFATE	CAPSULE;ORAL	CAPSULE	ORAL	KOSELUGO	ASTRAZENECA	EQ 10MG BASE		[]	2020-04-10	Apr 10, 2020	No	Yes	No	RX	ASTRAZENECA PHARMACEUTICALS LP	`392a389d28d7dcd431799fa5bf0d5e7fc5d0c822a57384240258ec0466d2f0ac`
3511	N	213756	002	SELUMETINIB SULFATE	CAPSULE;ORAL	CAPSULE	ORAL	KOSELUGO	ASTRAZENECA	EQ 25MG BASE		[]	2020-04-10	Apr 10, 2020	No	Yes	Yes	RX	ASTRAZENECA PHARMACEUTICALS LP	`6440e21a2773327a47a5fb67c86e4d531c9215a07243837a4de4d6b4ab6e9a18`
3512	N	019500	002	CLOFAZIMINE	CAPSULE;ORAL	CAPSULE	ORAL	LAMPRENE	NOVARTIS	50MG		[]	1986-12-15	Dec 15, 1986	No	Yes	No	DISCN	NOVARTIS PHARMACEUTICALS CORP	`7d378b12f87033d36e40a048dd5aee01320e5f60b501fe8ca8e3819d9ac1d3b9`
3513	N	019500	001	CLOFAZIMINE	CAPSULE;ORAL	CAPSULE	ORAL	LAMPRENE	NOVARTIS	100MG		[]	1986-12-15	Dec 15, 1986	No	No	No	DISCN	NOVARTIS PHARMACEUTICALS CORP	`2ae4731194da5b49ce3ae7a148d961e6f17326dbb9cc63dc25da8d38615dc261`
3514	A	086996	002	ASPIRIN; BUTALBITAL; CAFFEINE	CAPSULE;ORAL	CAPSULE	ORAL	LANORINAL	LANNETT	325MG;50MG;40MG	AA	["AA"]	1985-10-11	Oct 11, 1985	No	No	No	RX	LANNETT CO INC	`c9d08de789e8ba44b4469d4ab86566f3b2a7058703b6bf1531b1eb693a384fbf`
3515	N	018118	002	DIGOXIN	CAPSULE;ORAL	CAPSULE	ORAL	LANOXICAPS	GLAXOSMITHKLINE LLC	0.05MG		[]	1982-07-26	Jul 26, 1982	No	No	No	DISCN	GLAXOSMITHKLINE LLC	`b93d80ca451cbbeab44825fb6d2cecb07a3378d51ecef9f365ded6fff75b4873`
3516	N	018118	003	DIGOXIN	CAPSULE;ORAL	CAPSULE	ORAL	LANOXICAPS	GLAXOSMITHKLINE LLC	0.1MG		[]	1982-07-26	Jul 26, 1982	No	No	No	DISCN	GLAXOSMITHKLINE LLC	`03cdb2b0962d16b02016be98e1248d25806e144c8e4a5a2b1a9600a0b8315e88`
3517	N	018118	004	DIGOXIN	CAPSULE;ORAL	CAPSULE	ORAL	LANOXICAPS	GLAXOSMITHKLINE LLC	0.15MG		[]	1984-09-24	Sep 24, 1984	No	No	No	DISCN	GLAXOSMITHKLINE LLC	`3c0f46638b80eed2531056fcf858134fea5e840ee4b883f9c8c35f527941950d`
3518	N	018118	001	DIGOXIN	CAPSULE;ORAL	CAPSULE	ORAL	LANOXICAPS	GLAXOSMITHKLINE LLC	0.2MG		[]	1982-07-26	Jul 26, 1982	No	No	No	DISCN	GLAXOSMITHKLINE LLC	`ebd39697c0a8d72ba67d2be522fc8d9f25d25e3487a84c30c33a2554000f0187`
3519	N	016912	002	LEVODOPA	CAPSULE;ORAL	CAPSULE	ORAL	LARODOPA	ROCHE	100MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	HOFFMANN LA ROCHE INC	`48fdad2aa8969c6d2f8770ce23c1f2f725db9af9c6b968564b0bbbe3bc42046a`
3520	N	016912	001	LEVODOPA	CAPSULE;ORAL	CAPSULE	ORAL	LARODOPA	ROCHE	250MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	HOFFMANN LA ROCHE INC	`2f4a02157abba47b3cc0ea393222bee828dc6b0d47d44646d6939aee9a69fc04`
3521	N	016912	006	LEVODOPA	CAPSULE;ORAL	CAPSULE	ORAL	LARODOPA	ROCHE	500MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	HOFFMANN LA ROCHE INC	`d3b6a802b28cdb0f47fda32f0cdc23d1cf003b84875e2e1d924a0741048bc29d`
3522	N	206947	001	LENVATINIB MESYLATE	CAPSULE;ORAL	CAPSULE	ORAL	LENVIMA	EISAI INC	EQ 4MG BASE		[]	2015-02-13	Feb 13, 2015	No	Yes	No	RX	EISAI INC	`5751a13918af89e19af02d7885502e1257628e6b79d3fa86a6934509faf2e18d`
3523	N	206947	002	LENVATINIB MESYLATE	CAPSULE;ORAL	CAPSULE	ORAL	LENVIMA	EISAI INC	EQ 10MG BASE		[]	2015-02-13	Feb 13, 2015	No	Yes	Yes	RX	EISAI INC	`a119a3552aae8c7928c8c33524a273345aceb1e41db0b52fb67990e4dae683a0`
3524	N	020261	001	FLUVASTATIN SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	LESCOL	NOVARTIS	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1993-12-31	Dec 31, 1993	No	Yes	No	DISCN	NOVARTIS PHARMACEUTICALS CORP	`f65b8eca31ec014f5806d81206582a04f6bf0a6be8a560db30ddabc530e2e157`
3525	N	020261	002	FLUVASTATIN SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	LESCOL	NOVARTIS	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1993-12-31	Dec 31, 1993	No	Yes	No	DISCN	NOVARTIS PHARMACEUTICALS CORP	`c2f4047623999c844b7f1aaf5d57e486e4f8fa5d64a53ed5b3a3ef01ce92f6b3`
3526	A	211369	001	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	LEVOTHYROXINE SODIUM	TEVA PHARMS USA INC	0.075MG	AB	["AB"]	2020-10-28	Oct 28, 2020	No	No	No	RX	TEVA PHARMACEUTICALS USA INC	`85c1f4f3523574983590168321e3de34ea817ef4bd2c747b7a36c93b1a0c7ab7`
3527	A	213256	001	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	LEVOTHYROXINE SODIUM	TEVA PHARMS USA INC	0.088MG	AB	["AB"]	2021-01-06	Jan 6, 2021	No	No	No	RX	TEVA PHARMACEUTICALS USA INC	`229df4d9b47b0fb553198f838b48d723a4213bad6b46ca5eb7a06e3848599e03`
3528	A	213256	002	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	LEVOTHYROXINE SODIUM	TEVA PHARMS USA INC	0.1MG	AB	["AB"]	2021-01-06	Jan 6, 2021	No	No	No	RX	TEVA PHARMACEUTICALS USA INC	`a0abfcc9719f55f23b8e2f7bba3def29a1489fb353dd828271283d7a1510f05b`
3529	A	213256	003	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	LEVOTHYROXINE SODIUM	TEVA PHARMS USA INC	0.125MG	AB	["AB"]	2021-01-06	Jan 6, 2021	No	No	No	RX	TEVA PHARMACEUTICALS USA INC	`98c92b23b939cd0a079d396321a846a0bd104825a8b6c702a7f4d80d72b73c5d`
3530	A	211369	002	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	LEVOTHYROXINE SODIUM	TEVA PHARMS USA INC	0.15MG	AB	["AB"]	2020-10-28	Oct 28, 2020	No	No	No	RX	TEVA PHARMACEUTICALS USA INC	`0f8500fdb845e1ab563f702e0e335409987203e72d9e164e3044f7668accaa02`
3531	N	012750	001	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	CAPSULE;ORAL	CAPSULE	ORAL	LIBRAX	BAUSCH	5MG;2.5MG	AB	["AB"]		Approved Prior to Jan 1, 1982	Yes	Yes	Yes	RX	BAUSCH HEALTH US LLC	`004ebef5e5153c797017d4ed051aa46b3f35c0dc227de5b07c663473230d47ff`
3532	A	085461	001	CHLORDIAZEPOXIDE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	LIBRIUM	VALEANT PHARM INTL	5MG	AB	["AB"]		Approved Prior to Jan 1, 1982	Yes	No	No	RX	VALEANT PHARMACEUTICALS INTERNATIONAL	`63187492cb09ee30e0dd2110df0823cb223ea4c2822c62b1b75efb9c937a85bd`
3533	N	012249	002	CHLORDIAZEPOXIDE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	LIBRIUM	VALEANT PHARM INTL	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	VALEANT PHARMACEUTICALS INTERNATIONAL	`954e9b7b4c495a9233ee3189560c046a1609cb6a2d54236e9f9fe83d8b5cb4ff`
3534	A	085472	001	CHLORDIAZEPOXIDE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	LIBRIUM	VALEANT PHARM INTL	10MG	AB	["AB"]		Approved Prior to Jan 1, 1982	Yes	No	No	RX	VALEANT PHARMACEUTICALS INTERNATIONAL	`a97aecde2ce46903079da79e99f0ff92d7777df0832788227b702d6886266e18`
3535	N	012249	001	CHLORDIAZEPOXIDE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	LIBRIUM	VALEANT PHARM INTL	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	VALEANT PHARMACEUTICALS INTERNATIONAL	`e8bad935e1458de03de432e3ca320ab2f3f92fb0aa386157bf41778621aa7fb0`
3536	A	085475	001	CHLORDIAZEPOXIDE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	LIBRIUM	VALEANT PHARM INTL	25MG	AB	["AB"]		Approved Prior to Jan 1, 1982	Yes	No	Yes	RX	VALEANT PHARMACEUTICALS INTERNATIONAL	`3e96d51773aff1d00db993a20fd2e2dddca220ae7be712b16f97039984cfde81`
3537	N	012249	003	CHLORDIAZEPOXIDE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	LIBRIUM	VALEANT PHARM INTL	25MG 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	`9fb44c76c093cae4509c9fdc9af890c75db14d598a32e44a8058128a8a92c1a2`
3538	A	209564	001	LINACLOTIDE	CAPSULE;ORAL	CAPSULE	ORAL	LINACLOTIDE	MYLAN	145MCG		[]	2021-02-09	Feb 9, 2021	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`5a316469564a859a84d27deeb961f8b1e1adcb0a1aac61ccb063608f050030dd`
3539	A	209564	002	LINACLOTIDE	CAPSULE;ORAL	CAPSULE	ORAL	LINACLOTIDE	MYLAN	290MCG		[]	2021-02-09	Feb 9, 2021	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`44bed89908ebe994d36f6ba9f6788a369388d76909d12ff025bd0cdb39a55d17`
3540	N	050316	001	LINCOMYCIN HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	LINCOCIN	PHARMACIA AND UPJOHN	EQ 250MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	PHARMACIA AND UPJOHN CO	`6fe8bdc3813b7b64054784201f77a130827cc4a1abeb866467ba50c60e3585c2`
3541	N	050316	002	LINCOMYCIN HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	LINCOCIN	PHARMACIA AND UPJOHN	EQ 500MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	PHARMACIA AND UPJOHN CO	`6012d89fc3d24ec4c85f8cd7021f446d0d46cdcc9e78a36004e0c67a3490349d`
3542	N	202811	003	LINACLOTIDE	CAPSULE;ORAL	CAPSULE	ORAL	LINZESS	ALLERGAN	72MCG		[]	2017-01-25	Jan 25, 2017	No	Yes	Yes	RX	ALLERGAN SALES LLC	`39226ac9f3bd4b5d2733948c8776c4bbe5d9d556a157ded7fb475e0f5befb82f`
3543	N	202811	001	LINACLOTIDE	CAPSULE;ORAL	CAPSULE	ORAL	LINZESS	ALLERGAN	145MCG		[]	2012-08-30	Aug 30, 2012	No	Yes	Yes	RX	ALLERGAN SALES LLC	`eb9f555906a60b8a0bb317ee9572523ce2214c56118da6eb82eb7466e83b6e46`
3544	N	202811	002	LINACLOTIDE	CAPSULE;ORAL	CAPSULE	ORAL	LINZESS	ALLERGAN	290MCG		[]	2012-08-30	Aug 30, 2012	No	Yes	No	RX	ALLERGAN SALES LLC	`c30688c60ace5d747833c5af2c30a7b9925ee612568ad401a85abe28b29306a6`
3545	N	019304	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	LIPIDIL	ABBVIE	100MG		[]	1993-12-31	Dec 31, 1993	No	No	No	DISCN	ABBVIE INC	`0437979dbbaa4ef4ed5d42f9eb15f3032e1a6475836db7f42689233fdca5825c`
3546	N	021612	001	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	LIPOFEN	CIPHER PHARMS INC	50MG		[]	2006-01-11	Jan 11, 2006	No	Yes	No	RX	CIPHER PHARMACEUTICALS INC	`aa38ee47daa182c52ad8968422394dbe348113f04fa9dfefab87c875f4f6f5cc`
3547	N	021612	002	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	LIPOFEN	CIPHER PHARMS INC	100MG		[]	2006-01-11	Jan 11, 2006	No	No	No	DISCN	CIPHER PHARMACEUTICALS INC	`c7dfecd8480d019d140fe490494a6378aba757d7d19f574ba569b37865ffaeaf`
3548	N	021612	003	FENOFIBRATE	CAPSULE;ORAL	CAPSULE	ORAL	LIPOFEN	CIPHER PHARMS INC	150MG		[]	2006-01-11	Jan 11, 2006	No	Yes	Yes	RX	CIPHER PHARMACEUTICALS INC	`f63761baffee31997a81ac28099fee08e5cedae1a62935c729bf2a53e5b37296`
3549	A	076823	001	LITHIUM CARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	LITHIUM CARBONATE	ABLE	150MG		[]	2004-06-29	Jun 29, 2004	No	No	No	DISCN	ABLE LABORATORIES INC	`4a1c841c0c2db93c3b04c97d772199f067cc666227aea2e0af82811d3e0ae485`
3550	A	076121	001	LITHIUM CARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	LITHIUM CARBONATE	ABLE	300MG		[]	2001-09-27	Sep 27, 2001	No	No	No	DISCN	ABLE LABORATORIES INC	`3e361ab553bd1e3f0cde2e17e35728c716268f36f25ace67e9642fdbc2092b20`
3551	A	076823	002	LITHIUM CARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	LITHIUM CARBONATE	ABLE	300MG		[]	2004-06-29	Jun 29, 2004	No	No	No	DISCN	ABLE LABORATORIES INC	`0506964c9628d57018f46ad83e215f275a1446a26c88f475d1f8cb76e20f479e`