Orange Book snapshot 21: Products

Products page 80 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
3952	A	204228	002	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	AJANTA PHARMA LTD	40MG;1.1GM	AB	["AB"]	2016-07-15	Jul 15, 2016	No	No	No	RX	AJANTA PHARMA LTD	`1343d20ab55a0e9befff9a570083d4783c897fe7a248a26bf8db4392719ebe40`
3953	A	204922	001	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	AUROLIFE PHARMA LLC	20MG;1.1GM	AB	["AB"]	2016-08-19	Aug 19, 2016	No	No	No	RX	AUROLIFE PHARMA LLC	`bc1a91d60a6274f5f719108f37c31ea24aba82554f312af82e799a73cfd208af`
3954	A	204923	001	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	AUROLIFE PHARMA LLC	20MG;1.1GM		[]	2016-11-07	Nov 7, 2016	No	No	No	OTC	AUROLIFE PHARMA LLC	`a8ffe56fa07e60d9a2339b3f2d5ff8556a934d7c02503a844c26b884fb49a2bd`
3955	A	204922	002	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	AUROLIFE PHARMA LLC	40MG;1.1GM	AB	["AB"]	2016-08-19	Aug 19, 2016	No	No	No	RX	AUROLIFE PHARMA LLC	`35b1a43f229134e6dc3c5639f57d1928dfebf37d48c090d153ed196bf0443f4c`
3956	A	204068	001	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	DR REDDYS LABS LTD	20MG;1.1GM	AB	["AB"]	2016-07-15	Jul 15, 2016	No	No	No	RX	DR REDDYS LABORATORIES LTD	`5115232013f032678dec8245f77d961c1a0bce37c2cc57600d0d06835969a34a`
3957	A	204068	002	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	DR REDDYS LABS LTD	40MG;1.1GM	AB	["AB"]	2016-07-15	Jul 15, 2016	No	No	No	RX	DR REDDYS LABORATORIES LTD	`6ab42d0fd9a9e824c24bc794cae0b08e57676d961ff47e500dfb2c378980cba8`
3958	A	212587	001	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	GUARDIAN DRUG	20MG;1.1GM	AB	["AB"]	2020-04-30	Apr 30, 2020	No	No	No	RX	GUARDIAN DRUG CO	`138dede7c22c953ac0bc0ec1b4aa1f998633fb523e39affb74c855fd8b507432`
3959	A	212587	002	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	GUARDIAN DRUG	40MG;1.1GM	AB	["AB"]	2020-04-30	Apr 30, 2020	No	No	No	RX	GUARDIAN DRUG CO	`90b146c6f41286a4245d4c71e32f74b2103e5e7c5949b60bd4b975860c2ba1a0`
3960	A	078966	001	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	PAR PHARM	20MG;1.1GM		[]	2010-05-25	May 25, 2010	No	No	No	DISCN	PAR PHARMACEUTICAL	`ef6fc1700428499abfc771ace698b4fed907b3afcb8088e4033c2bff6d28a88f`
3961	A	201946	001	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	PAR PHARM	20MG;1.1GM		[]	2016-07-15	Jul 15, 2016	No	No	No	DISCN	PAR PHARMACEUTICAL INC	`3f4f360839d854729d75c4a26680a36a7a2c595e0c81bae2299cc4843c77800b`
3962	A	078966	002	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	PAR PHARM	40MG;1.1GM		[]	2010-05-25	May 25, 2010	No	No	No	DISCN	PAR PHARMACEUTICAL	`cda741d25501cbe6cc3445061628483f4d718932943e144197ee61e068726ac6`
3963	A	201361	001	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	PERRIGO R AND D	20MG;1.1GM		[]	2016-07-15	Jul 15, 2016	No	No	No	OTC	PERRIGO R AND D CO	`929e0c150ea98046ece50e6412cec580cb771a2f20b861f23ea0a1550f0eb8a3`
3964	A	207476	001	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	SCIEGEN PHARMS INC	20MG;1.1GM	AB	["AB"]	2016-12-06	Dec 6, 2016	No	No	No	RX	SCIEGEN PHARMACEUTICALS INC	`449419656fefe484a29c7df438f698a24f9fab2c3507a89664672a85ee0468e2`
3965	A	207476	002	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	SCIEGEN PHARMS INC	40MG;1.1GM	AB	["AB"]	2016-12-06	Dec 6, 2016	No	No	No	RX	SCIEGEN PHARMACEUTICALS INC	`6a6ffde9c63365a4053d31d58c73cb7b7c737e315abf3604e35aa43e8cb7afd3`
3966	A	204137	001	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	UNICORN	20MG;1.1GM		[]	2016-07-15	Jul 15, 2016	No	No	No	DISCN	UNICORN PHARMACEUTICALS	`24855af3f1c90b64b8eb5bdfbc78969adb2a3064bc0affbff735e2e54355f76e`
3967	A	203290	001	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	ZYDUS PHARMS	20MG;1.1GM	AB	["AB"]	2018-05-25	May 25, 2018	No	No	No	RX	ZYDUS PHARMACEUTICALS USA INC	`363b6ceefca32f6f846dd9c5502b83105915847c9f60ebc542dc03f379c6a9fd`
3968	A	203345	001	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	ZYDUS PHARMS	20MG;1.1GM		[]	2018-03-16	Mar 16, 2018	No	No	No	OTC	ZYDUS PHARMACEUTICALS USA INC	`f07c8cb84fb78d54b545c314ca918a5147838acd4a05fc637ed552aceb610dd8`
3969	A	203290	002	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	CAPSULE	ORAL	OMEPRAZOLE AND SODIUM BICARBONATE	ZYDUS PHARMS	40MG;1.1GM	AB	["AB"]	2018-05-25	May 25, 2018	No	No	No	RX	ZYDUS PHARMACEUTICALS USA INC	`0b7ea2546d5ea0e29ae07b7774ae4000569058be98a8f05e687fd16af8ac8aa6`
3970	N	050739	001	CEFDINIR	CAPSULE;ORAL	CAPSULE	ORAL	OMNICEF	ABBVIE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1997-12-04	Dec 4, 1997	No	Yes	No	DISCN	ABBVIE INC	`ab9015d7122955ec7918d3716a1adca34483b4a283b31332895e8736097b3377`
3971	A	060624	001	AMPICILLIN/AMPICILLIN TRIHYDRATE	CAPSULE;ORAL	CAPSULE	ORAL	OMNIPEN (AMPICILLIN)	WYETH AYERST	250MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	WYETH AYERST LABORATORIES	`a60e7e960a6889b828a611ed286278ee6e1edd937a2b9b3c639e183191af07de`
3972	A	060624	002	AMPICILLIN/AMPICILLIN TRIHYDRATE	CAPSULE;ORAL	CAPSULE	ORAL	OMNIPEN (AMPICILLIN)	WYETH AYERST	500MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	WYETH AYERST LABORATORIES	`bc0523ca015a2424f9a37adda2cdae645dd6533196f4403526a2c6a38dc27245`
3973	N	204977	001	OMEGA-3-ACID ETHYL ESTERS TYPE A	CAPSULE;ORAL	CAPSULE	ORAL	OMTRYG	OSMOTICA	1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS		[]	2014-04-23	Apr 23, 2014	No	Yes	No	DISCN	OSMOTICA KERESKEDELMI ES SZOLGALTATO KFT	`79d1fbf3743e40c4e07aecbd0fd476c7ddbcce0223b85bf9a006e7c3e3e8edb0`
3974	A	086511	001	PHENTERMINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	ONA-MAST	MAST MM	30MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	MM MAST AND CO	`332eb06482df9461a4c60c046b0b222838480aa11ff792df39fd616fbe6351e7`
3975	A	086516	001	PHENTERMINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	ONA-MAST	MAST MM	30MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	MM MAST AND CO	`669ef32c4758d2cac6d33e73c7d13d0b2e23ac98c48b4947f99158dabbd10663`
3976	N	212489	001	OPICAPONE	CAPSULE;ORAL	CAPSULE	ORAL	ONGENTYS	NEUROCRINE	25MG		[]	2020-04-24	Apr 24, 2020	No	Yes	No	RX	NEUROCRINE BIOSCIENCES INC	`304adfa77861e2410c34bc05ab95ca7cdf30adcaa05d5683e76a37affe712e15`
3977	N	212489	002	OPICAPONE	CAPSULE;ORAL	CAPSULE	ORAL	ONGENTYS	NEUROCRINE	50MG		[]	2020-04-24	Apr 24, 2020	No	Yes	Yes	RX	NEUROCRINE BIOSCIENCES INC	`2dcf250b58ef5320a73efbb3656eb9dff628f3880eaac936a575620daf6188b8`
3978	N	050805	001	DOXYCYCLINE	CAPSULE;ORAL	CAPSULE	ORAL	ORACEA	GALDERMA LABS LP	40MG		[]	2006-05-26	May 26, 2006	No	Yes	Yes	RX	GALDERMA LABORATORIES LP	`6df0175a15869a80c220a4ba7f89e12636c7d83987e36e8e2ecbfb4b78129ff7`
3979	N	012967	001	IPODATE SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	ORAGRAFIN SODIUM	BRACCO	500MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	BRACCO DIAGNOSTICS INC	`e7e74fca10d22d0c0cfbfd6b9b6c84e31474a54af0818c5592b308205aa24c39`
3980	N	021232	001	NITISINONE	CAPSULE;ORAL	CAPSULE	ORAL	ORFADIN	SWEDISH ORPHAN	2MG	AB	["AB"]	2002-01-18	Jan 18, 2002	No	Yes	No	RX	SWEDISH ORPHAN BIOVITRUM AB PUBL	`90b45541a885865ed274de980027fc4f3bc262d832d008fcb89b0eb3408bbf74`
3981	N	021232	002	NITISINONE	CAPSULE;ORAL	CAPSULE	ORAL	ORFADIN	SWEDISH ORPHAN	5MG	AB	["AB"]	2002-01-18	Jan 18, 2002	No	Yes	No	RX	SWEDISH ORPHAN BIOVITRUM AB PUBL	`fb3563e5ffd9d9c16ac85ed16f32e3f60515d79599a4e3872a769771f23da6b3`
3982	N	021232	003	NITISINONE	CAPSULE;ORAL	CAPSULE	ORAL	ORFADIN	SWEDISH ORPHAN	10MG	AB	["AB"]	2002-01-18	Jan 18, 2002	No	Yes	No	RX	SWEDISH ORPHAN BIOVITRUM AB PUBL	`6cd06104c809f994802039c4b162cccebe4b9193dfa1fe9ead96404fd405cf7a`
3983	N	021232	004	NITISINONE	CAPSULE;ORAL	CAPSULE	ORAL	ORFADIN	SWEDISH ORPHAN	20MG		[]	2016-06-13	Jun 13, 2016	No	Yes	Yes	RX	SWEDISH ORPHAN BIOVITRUM AB PUBL	`45b1ae0147946686661a6c9417cd854e36707ae96d442afc49ef41a28acba74e`
3984	N	213388	001	ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	ORIAHNN (COPACKAGED)	ABBVIE INC	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE		[]	2020-05-29	May 29, 2020	No	Yes	Yes	RX	ABBVIE INC	`0692606b595a38756d16e90a4326b7a5105b0f7c577b8074866f2bdb7664af4f`
3985	N	214094	001	BEROTRALSTAT HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	ORLADEYO	BIOCRYST	EQ 110MG BASE		[]	2020-12-03	Dec 3, 2020	No	Yes	No	RX	BIOCRYST PHARMACEUTICALS INC	`75072bd14a3d34a4a09eee8afeddab5f54dfc46b4b5fbfcb53a4c8a63154f1d4`
3986	N	214094	002	BEROTRALSTAT HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	ORLADEYO	BIOCRYST	EQ 150MG BASE		[]	2020-12-03	Dec 3, 2020	No	Yes	Yes	RX	BIOCRYST PHARMACEUTICALS INC	`62b6a93f57f3588f9a6e5215c1469ab8bd4cebef82c752d65310c78340d6201f`
3987	N	018754	001	KETOPROFEN	CAPSULE;ORAL	CAPSULE	ORAL	ORUDIS	WYETH AYERST	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1987-07-31	Jul 31, 1987	No	Yes	No	DISCN	WYETH AYERST LABORATORIES	`1793288370327a5ca1b7037656c1b0687310dd9d83363dd1f2e181366c41802c`
3988	N	018754	002	KETOPROFEN	CAPSULE;ORAL	CAPSULE	ORAL	ORUDIS	WYETH AYERST	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1986-01-09	Jan 9, 1986	No	Yes	No	DISCN	WYETH AYERST LABORATORIES	`a73945b4e829a68fc14e75a3a30f7243c86433e17991f6e1843b7c58ee63e23e`
3989	N	018754	003	KETOPROFEN	CAPSULE;ORAL	CAPSULE	ORAL	ORUDIS	WYETH AYERST	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1986-01-09	Jan 9, 1986	No	Yes	No	DISCN	WYETH AYERST LABORATORIES	`15f3d1ede99c4e1c38dc6d32eb6b06630cfc9ba0d58ee025fbba05bcc75855b9`
3990	A	211823	001	OSELTAMIVIR PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	OSELTAMIVIR PHOSPHATE	ALEMBIC PHARMS LTD	EQ 30MG BASE	AB	["AB"]	2019-06-24	Jun 24, 2019	No	No	No	RX	ALEMBIC PHARMACEUTICALS LTD	`f0686df6d6d78d612a6bd9db82fc79da2084fbc862e3d319f5a542cc0b39f13f`
3991	A	211823	002	OSELTAMIVIR PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	OSELTAMIVIR PHOSPHATE	ALEMBIC PHARMS LTD	EQ 45MG BASE	AB	["AB"]	2019-06-24	Jun 24, 2019	No	No	No	RX	ALEMBIC PHARMACEUTICALS LTD	`ce0c56a9cbf42fbe9a99e064b8d6231eb1ef9753ab81a1fa31ad925678917f21`
3992	A	211823	003	OSELTAMIVIR PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	OSELTAMIVIR PHOSPHATE	ALEMBIC PHARMS LTD	EQ 75MG BASE	AB	["AB"]	2019-06-24	Jun 24, 2019	No	No	No	RX	ALEMBIC PHARMACEUTICALS LTD	`64c5e723d121d97e02aad8dcf61dd613fb0791750b387d18a8dfcc855948766b`
3993	A	209093	001	OSELTAMIVIR PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	OSELTAMIVIR PHOSPHATE	AMNEAL PHARMS	EQ 30MG BASE	AB	["AB"]	2017-05-17	May 17, 2017	No	No	No	RX	AMNEAL PHARMACEUTICALS OF NEW YORK LLC	`2dea20b2b009bb8c3da7358e01ee6437304971b83477a07101532f376798c73b`
3994	A	209093	002	OSELTAMIVIR PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	OSELTAMIVIR PHOSPHATE	AMNEAL PHARMS	EQ 45MG BASE	AB	["AB"]	2017-05-17	May 17, 2017	No	No	No	RX	AMNEAL PHARMACEUTICALS OF NEW YORK LLC	`9f4e4dffc4bb8e07ffd4f6e3ef3454be7e29ee842fe9b41ee2b85cc4fba5b9c6`
3995	A	209093	003	OSELTAMIVIR PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	OSELTAMIVIR PHOSPHATE	AMNEAL PHARMS	EQ 75MG BASE	AB	["AB"]	2017-05-17	May 17, 2017	No	No	No	RX	AMNEAL PHARMACEUTICALS OF NEW YORK LLC	`6501a535d8ae58af98f44734eda52f391055687aef2548e913516aac2f914702`
3996	A	209438	001	OSELTAMIVIR PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	OSELTAMIVIR PHOSPHATE	HETERO LABS LTD III	EQ 30MG BASE	AB	["AB"]	2018-02-23	Feb 23, 2018	No	No	No	RX	HETERO LABS LTD UNIT III	`c06490ba109b76b2b6adcc2b814fcb405b87c3c97cdf9403922a2bdeba125994`
3997	A	209438	002	OSELTAMIVIR PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	OSELTAMIVIR PHOSPHATE	HETERO LABS LTD III	EQ 45MG BASE	AB	["AB"]	2018-02-23	Feb 23, 2018	No	No	No	RX	HETERO LABS LTD UNIT III	`68fa230c5200ec0eaea3e7e6ba219809f0cb1b33a1625e79040edaf614151a6e`
3998	A	209438	003	OSELTAMIVIR PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	OSELTAMIVIR PHOSPHATE	HETERO LABS LTD III	EQ 75MG BASE	AB	["AB"]	2018-02-23	Feb 23, 2018	No	No	No	RX	HETERO LABS LTD UNIT III	`5d410546c04693531bbf8dac8f6367062366e10d629244bedc829797dbc77273`
3999	A	208348	001	OSELTAMIVIR PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	OSELTAMIVIR PHOSPHATE	LUPIN	EQ 30MG BASE	AB	["AB"]	2018-01-09	Jan 9, 2018	No	No	No	RX	LUPIN INC	`9b76af810843e482917166ecd78d7e74105280f0fe6c25ae3c9e1c9b26a6f2de`
4000	A	208348	002	OSELTAMIVIR PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	OSELTAMIVIR PHOSPHATE	LUPIN	EQ 45MG BASE	AB	["AB"]	2018-01-09	Jan 9, 2018	No	No	No	RX	LUPIN INC	`4aa59b8c22a40f5d43258dea6dcf75393583b29536f3d74828236b1d289e299f`
4001	A	208348	003	OSELTAMIVIR PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	OSELTAMIVIR PHOSPHATE	LUPIN	EQ 75MG BASE	AB	["AB"]	2018-01-09	Jan 9, 2018	No	No	No	RX	LUPIN INC	`639d7d2bcbce2f26d7f6ca54e3fca1b1f5ac4ae3c37cacf832f84cbe9b016c5c`