Orange Book snapshot 21: Products

Products page 19 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
902	N	011945	001	DIPHENYLPYRALINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	HISPRIL	GLAXOSMITHKLINE	5MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	GLAXOSMITHKLINE	`94b0f5e0e9888d949ad7f6268a55527ed9cdccf7b44eefda5bbcdd022ac56b94`
903	A	206986	001	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	HYDROCODONE BITARTRATE	ALVOGEN	10MG	AB	["AB"]	2020-01-21	Jan 21, 2020	No	No	No	RX	ALVOGEN INC	`f5a2aa95d293d60ca5af27e30b6712a083e6faf1f2f665a5877e3f8e7fca69ed`
904	A	206986	002	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	HYDROCODONE BITARTRATE	ALVOGEN	15MG	AB	["AB"]	2020-01-21	Jan 21, 2020	No	No	No	RX	ALVOGEN INC	`8c12e65b89a2297d2b810532963f473e378c84b3e0e4e089e5bfc799c9ab5d44`
905	A	206986	003	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	HYDROCODONE BITARTRATE	ALVOGEN	20MG	AB	["AB"]	2020-01-21	Jan 21, 2020	No	No	No	RX	ALVOGEN INC	`39ee584637a6c0ef99338447b495dac624e0360e04b2e4557017140d130083a6`
906	A	206986	004	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	HYDROCODONE BITARTRATE	ALVOGEN	30MG	AB	["AB"]	2020-01-21	Jan 21, 2020	No	No	No	RX	ALVOGEN INC	`ab5af61134c9969a46423e2b8309ffb0e0cc92659289331b0e65c8eff4bb37e3`
907	A	206986	005	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	HYDROCODONE BITARTRATE	ALVOGEN	40MG	AB	["AB"]	2020-01-21	Jan 21, 2020	No	No	No	RX	ALVOGEN INC	`1f68d58b24b9d94654f10a1aa461630bc87cc5b5035fc8fc3360f1f67f2575c0`
908	A	206986	006	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	HYDROCODONE BITARTRATE	ALVOGEN	50MG	AB	["AB"]	2020-01-21	Jan 21, 2020	No	No	No	RX	ALVOGEN INC	`da9ef90279c41dfeb767be35755bfd0dd4013e3aa33bdc74ea1901fba6d4e96c`
909	N	018553	004	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDERAL LA	ANI PHARMS INC	60MG	AB	["AB"]	1987-03-18	Mar 18, 1987	No	Yes	No	RX	ANI PHARMACEUTICALS INC	`c261ad63ffa889bc519009dea68b8b87481a13c4293be183ea2b7036eef20f7b`
910	N	018553	002	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDERAL LA	ANI PHARMS INC	80MG	AB	["AB"]	1983-04-19	Apr 19, 1983	No	Yes	No	RX	ANI PHARMACEUTICALS INC	`93cb59b02c854cf9635d8e8b7236938f807af73751c728fa19802739608c17a8`
911	N	018553	003	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDERAL LA	ANI PHARMS INC	120MG	AB	["AB"]	1983-04-19	Apr 19, 1983	No	Yes	No	RX	ANI PHARMACEUTICALS INC	`2f0a4b67975e846e0e66d47901d5667e932184f7416c3e20f5027bc3d6d0b764`
912	N	018553	001	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDERAL LA	ANI PHARMS INC	160MG	AB	["AB"]	1983-04-19	Apr 19, 1983	No	Yes	Yes	RX	ANI PHARMACEUTICALS INC	`d2643c7e416f7ce7c57d0a83af0daa7e65b0e1f2e911065b094ebbf7804018e9`
913	N	019059	002	HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDERIDE LA 120/50	WYETH AYERST	50MG;120MG		[]	1985-07-03	Jul 3, 1985	No	No	No	DISCN	WYETH AYERST LABORATORIES	`06639ea77a874eb5a4213c6c7ac659e24b78a243a0336ff3714b19bcd98a2daa`
914	N	019059	003	HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDERIDE LA 160/50	WYETH AYERST	50MG;160MG		[]	1985-07-03	Jul 3, 1985	No	No	No	DISCN	WYETH AYERST LABORATORIES	`5381eb2d9592b0d4f00ac9dcf8211ddbd8d6a4eb1eb527f531783a412d358937`
915	N	019059	001	HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDERIDE LA 80/50	WYETH AYERST	50MG;80MG		[]	1985-07-03	Jul 3, 1985	No	No	No	DISCN	WYETH AYERST LABORATORIES	`00c280fa04b7150ca6dbd97d321025e279bec881594760b5fa60a1318f586bf6`
916	N	018185	001	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDOCIN SR	EGALET	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1982-02-23	Feb 23, 1982	No	Yes	No	DISCN	EGALET US INC	`254125e59d5cc22b38440af3145c7fe47f6534e568ba00b5bb6e552eaa1abf4d`
917	A	076114	001	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDOMETHACIN	ABLE	75MG		[]	2002-02-06	Feb 6, 2002	No	No	No	DISCN	ABLE LABORATORIES INC	`048078271760f0116a6cce55a1a6f3cdd700d880b44c60837f513becd0bd7518`
918	A	091549	001	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDOMETHACIN	AMNEAL PHARMS	75MG	AB	["AB"]	2010-12-01	Dec 1, 2010	No	No	No	RX	AMNEAL PHARMACEUTICALS	`03edb2d2fb713c8d640b8eb49ad85d5cd253bbe3366b0f5a760c4a04ff90792a`
919	A	204243	001	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDOMETHACIN	AUROBINDO PHARMA LTD	75MG		[]	2016-12-27	Dec 27, 2016	No	No	No	DISCN	AUROBINDO PHARMA LTD	`4e4c95708224dbcaa2b55d3b9b49f18461b50f058e5aab01de3878fcd5c5ffe9`
920	A	079175	001	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDOMETHACIN	AVANTHI INC	75MG	AB	["AB"]	2009-03-06	Mar 6, 2009	No	No	No	RX	AVANTHI INC	`b8096e78609b3b4b1a95718f509fb398ae612a0b3b833d3015dd0887c3160778`
921	A	200529	001	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDOMETHACIN	CHARTWELL RX	75MG	AB	["AB"]	2010-11-30	Nov 30, 2010	No	No	No	RX	CHARTWELL RX SCIENCES LLC	`be682c1b3a73f98ff3afd2241748d1066501db70e8ef69082a299a54e85dc44a`
922	A	203501	001	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDOMETHACIN	GLENMARK PHARMS LTD	75MG	AB	["AB"]	2017-06-22	Jun 22, 2017	No	No	No	RX	GLENMARK PHARMACEUTICALS LTD	`76fd061805161c8decd3ec2ec797348dae16e2d0abbbc3f6bfa5ff0f4fab539b`
923	A	201807	001	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDOMETHACIN	HETERO LABS LTD III	75MG	AB	["AB"]	2012-09-28	Sep 28, 2012	No	No	No	RX	HETERO LABS LTD UNIT III	`91c4de589b8e87f2b61289ad9f776ce21eca0b96d9cb080377e8affc50ba79bd`
924	A	072410	001	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDOMETHACIN	INWOOD LABS	75MG		[]	1989-03-15	Mar 15, 1989	No	No	No	DISCN	INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC	`34bbf3ebb182cbd09a3799b7d61755e41d10e957fd81cc7b33c8610ba637309c`
925	A	202706	001	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDOMETHACIN	JUBILANT GENERICS	75MG	AB	["AB"]	2015-10-05	Oct 5, 2015	No	No	No	RX	JUBILANT GENERICS LTD	`10ffd25c46c3315499ad9751555d2a371c804e70f6b113a7b490de98697790b0`
926	A	202139	001	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDOMETHACIN	MYLAN	75MG		[]	2014-03-20	Mar 20, 2014	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`35c734276aae5cd255049eb687a855942121994c997d5837e2fcff57d2e7b133`
927	A	204853	001	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDOMETHACIN	NOVAST LABS	75MG	AB	["AB"]	2017-05-08	May 8, 2017	No	No	No	RX	NOVAST LABORATORIES LTD	`9af2e463913eaaded6e98c41395195a17622c89ec737351f2783d013620578a8`
928	A	074464	001	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDOMETHACIN	SANDOZ	75MG	AB	["AB"]	1998-05-28	May 28, 1998	No	No	Yes	RX	SANDOZ INC	`0397c2edd8975842a3682ac9e956dafe7bc30dd5261409530768920c0567a2b9`
929	A	202572	001	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDOMETHACIN	WATSON LABS INC	75MG		[]	2013-12-09	Dec 9, 2013	No	No	No	DISCN	WATSON LABORATORIES INC	`94b81ca63bf5afdc3b4c4c443ee287577ab9bed35fab823ed8327739d5c0943d`
930	A	202711	001	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INDOMETHACIN	ZYDUS PHARMS	75MG	AB	["AB"]	2017-09-25	Sep 25, 2017	No	No	No	RX	ZYDUS PHARMACEUTICALS USA INC	`9713911ab942a68466c3f3a7abc1e3efce0a9f677b088897b7dc4f3a592e820b`
931	N	021438	001	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INNOPRAN XL	ANI PHARMS INC	80MG	BX	["BX"]	2003-03-12	Mar 12, 2003	No	Yes	No	RX	ANI PHARMACEUTICALS INC	`51748c57e6c713342a1a4a33232cb45ab1f754093fdf5687feb6c99017028493`
932	N	021438	002	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	INNOPRAN XL	ANI PHARMS INC	120MG	BX	["BX"]	2003-03-12	Mar 12, 2003	No	Yes	Yes	RX	ANI PHARMACEUTICALS INC	`9ef9af7b68896fbe63e1290d418105b0489d307eb16e169f36bf7e2720890972`
933	N	011613	004	PHENTERMINE RESIN COMPLEX	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	IONAMIN	UCB INC	EQ 15MG BASE 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	UCB INC	`40bf9aad274acf122f32a349ad22765188693d4bdfb0d1927a2ad65b13d8ce16`
934	N	011613	002	PHENTERMINE RESIN COMPLEX	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	IONAMIN	UCB INC	EQ 30MG BASE 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	UCB INC	`b90bbc27ec64b1a758fe979b0440b2aa454cc42720d86b03fbf7d03f2e4471ae`
935	N	018747	001	CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	ISOCLOR	FISONS	8MG;120MG		[]	1986-03-06	Mar 6, 1986	No	No	No	DISCN	FISONS CORP	`2b792e7b204b29ec481720da1afae5370e615ed0c39c014b7dddbe60651cb75c`
936	N	012882	002	ISOSORBIDE DINITRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	ISORDIL	WYETH AYERST	40MG		[]	1988-07-29	Jul 29, 1988	No	No	No	DISCN	WYETH AYERST LABORATORIES	`416f0206ab38816e11eee3e1e17a826d60d91e43b752088d20d7531319104c53`
937	N	209311	001	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	JORNAY PM	IRONSHORE PHARMS	20MG		[]	2018-08-08	Aug 8, 2018	No	Yes	No	RX	IRONSHORE PHARMACEUTICALS AND DEVELOPMENT INC	`2734de9d5cbc0deaf27c0a42e368b39d04f47f536d74962f9a673a0e7566a2b0`
938	N	209311	002	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	JORNAY PM	IRONSHORE PHARMS	40MG		[]	2018-08-08	Aug 8, 2018	No	Yes	No	RX	IRONSHORE PHARMACEUTICALS AND DEVELOPMENT INC	`60dca36a8550d048bb400b8d0ef0a907f24fca39ce17ef9d5d47ab90ebd2e616`
939	N	209311	003	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	JORNAY PM	IRONSHORE PHARMS	60MG		[]	2018-08-08	Aug 8, 2018	No	Yes	No	RX	IRONSHORE PHARMACEUTICALS AND DEVELOPMENT INC	`1a0e4fd7bca8a2d7d648a8f53f61f3a738763922bd173b3aa1ee6c1373da2f63`
940	N	209311	004	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	JORNAY PM	IRONSHORE PHARMS	80MG		[]	2018-08-08	Aug 8, 2018	No	Yes	No	RX	IRONSHORE PHARMACEUTICALS AND DEVELOPMENT INC	`11c27fe64a303a5573925dab2ee58793980cdc7e3bb0d9857a93693b9312f1eb`
941	N	209311	005	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	JORNAY PM	IRONSHORE PHARMS	100MG		[]	2018-08-08	Aug 8, 2018	No	Yes	Yes	RX	IRONSHORE PHARMACEUTICALS AND DEVELOPMENT INC	`20c62689cb4aef4d444640c6ae373d1bc35bafe3ebe7f580313237c3e82947e6`
942	A	073398	001	POTASSIUM CHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	K-LEASE	SAVAGE LABS	8MEQ		[]	1992-01-28	Jan 28, 1992	No	No	No	DISCN	SAVAGE LABORATORIES INC DIV ALTANA INC	`36648aadf489e4a304104162ce026d48d3e8aa38d97d426d8b3184d082b5e3b6`
943	A	072427	001	POTASSIUM CHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	K-LEASE	SAVAGE LABS	10MEQ		[]	1990-03-28	Mar 28, 1990	No	No	No	DISCN	SAVAGE LABORATORIES INC DIV ALTANA INC	`dcc589acd7da43c44f7a67b7a21558553b7e5d99304f9b4ae31b4100d86c5137`
944	N	020616	008	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	KADIAN	ALLERGAN	10MG	AB	["AB"]	2007-04-20	Apr 20, 2007	No	Yes	Yes	RX	ALLERGAN SALES LLC	`4e6a5686fefef8133e48620fa0f1c53a356f02e34001a29d00a85a697fc779f4`
945	N	020616	001	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	KADIAN	ALLERGAN	20MG	AB	["AB"]	1996-07-03	Jul 3, 1996	No	Yes	No	RX	ALLERGAN SALES LLC	`97466d0c26ad2be55a33c0fd27963b36640f216672a315c7eb4f1aaa8cdd1e6d`
946	N	020616	004	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	KADIAN	ALLERGAN	30MG	AB	["AB"]	2001-03-09	Mar 9, 2001	No	Yes	No	RX	ALLERGAN SALES LLC	`94ad1de658b5424cd9b90965d52a3089148a00e62019099f3a0c38be84e6054e`
947	N	020616	009	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	KADIAN	ALLERGAN	40MG	AB	["AB"]	2012-07-09	Jul 9, 2012	No	Yes	No	RX	ALLERGAN SALES LLC	`0d282da1bb02a095042a7d8777ed18f85ab1e0dc00f12bcde42107a844e3681f`
948	N	020616	002	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	KADIAN	ALLERGAN	50MG	AB	["AB"]	1996-07-03	Jul 3, 1996	No	Yes	No	RX	ALLERGAN SALES LLC	`a00f305630dcc1a1ce4686b2cf3972c1dfbcfa464d9a57285b1b8115e493ab66`
949	N	020616	005	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	KADIAN	ALLERGAN	60MG	AB	["AB"]	2001-03-09	Mar 9, 2001	No	Yes	No	RX	ALLERGAN SALES LLC	`556ade8c6bc7d48e1c2e8feab43bbc141a3a0c98df5d7fac0d5ae0446e96595a`
950	N	020616	010	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	KADIAN	ALLERGAN	70MG		[]	2012-07-09	Jul 9, 2012	No	Yes	No	RX	ALLERGAN SALES LLC	`8b5249fb1456951a1549ac3e6a32541843dbe7fb9a9524fc73f349df24cd2311`
951	N	020616	006	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	KADIAN	ALLERGAN	80MG	AB	["AB"]	2006-10-27	Oct 27, 2006	No	Yes	No	RX	ALLERGAN SALES LLC	`da7fe088aebd14699b022c8015e44c6f61efdb3f8aa75c015735ec7e789d7335`