Orange Book snapshot 21: Products

Products page 29 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
1402	A	075138	001	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	VERAPAMIL HYDROCHLORIDE	MYLAN	120MG	AB	["AB"]	1999-04-20	Apr 20, 1999	No	No	No	RX	MYLAN PHARMACEUTICALS INC	`73dddee53a2c35deca13afcdc440555511c3f4fba3a273507f2f13043b61a2af`
1403	A	075138	002	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	VERAPAMIL HYDROCHLORIDE	MYLAN	180MG	AB	["AB"]	1999-04-20	Apr 20, 1999	No	No	No	RX	MYLAN PHARMACEUTICALS INC	`e43bab7176c00b7972b9fdb2acfe4546a5b244905f862a1ce946a0119ecae250`
1404	A	078306	002	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	VERAPAMIL HYDROCHLORIDE	MYLAN	200MG		[]	2007-08-09	Aug 9, 2007	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`03bc0389293a6e81c9eff87b8976b64aea31c02603fff96d680e3235853c8d5c`
1405	A	075138	003	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	VERAPAMIL HYDROCHLORIDE	MYLAN	240MG	AB	["AB"]	1999-04-20	Apr 20, 1999	No	No	No	RX	MYLAN PHARMACEUTICALS INC	`0ed2eafa4477081128a251b24c2d8385c1df146c06685d2ebe803013123b975e`
1406	A	078306	003	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	VERAPAMIL HYDROCHLORIDE	MYLAN	300MG		[]	2007-08-09	Aug 9, 2007	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`b5d2ea6e6673031ae778d37e8d7ce64cfb1bb18a8d78532aae3e4d7336eba6ea`
1407	N	019614	001	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	VERELAN	RECRO GAINESVILLE	120MG	AB	["AB"]	1990-05-29	May 29, 1990	No	Yes	No	RX	RECRO GAINESVILLE LLC	`f174adedeac455d76a8ea334d8cc809cb3959e0e0004832d7094e498241264eb`
1408	N	019614	003	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	VERELAN	RECRO GAINESVILLE	180MG	AB	["AB"]	1992-01-09	Jan 9, 1992	No	Yes	No	RX	RECRO GAINESVILLE LLC	`5909189bb8b711a7e9cc7a58b19843a4a500d4513e7acbc59bdc8f3b96440d91`
1409	N	019614	002	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	VERELAN	RECRO GAINESVILLE	240MG	AB	["AB"]	1990-05-29	May 29, 1990	No	Yes	No	RX	RECRO GAINESVILLE LLC	`99714e2a5b70eeddb8a3e441719bb165db61a72e9e68aa49a7fee3ab1740352d`
1410	N	019614	004	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	VERELAN	RECRO GAINESVILLE	360MG		[]	1996-05-10	May 10, 1996	No	Yes	Yes	RX	RECRO GAINESVILLE LLC	`b67acb52acd270d8323ef5151505b9130236b1337a2b30f1eaad9c6e9088a4a1`
1411	N	020943	001	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	VERELAN PM	RECRO GAINESVILLE	100MG		[]	1998-11-25	Nov 25, 1998	No	Yes	No	RX	RECRO GAINESVILLE LLC	`a8993ed70b274c685bd431d40ad838bc7db58cadf8c3f5f180eed88df734a992`
1412	N	020943	002	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	VERELAN PM	RECRO GAINESVILLE	200MG		[]	1998-11-25	Nov 25, 1998	No	Yes	No	RX	RECRO GAINESVILLE LLC	`b1d94c22daedcf7e544a665bb0a7c41f16ec6d809e6e31f13bf5757366a39740`
1413	N	020943	003	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	VERELAN PM	RECRO GAINESVILLE	300MG		[]	1998-11-25	Nov 25, 1998	No	Yes	Yes	RX	RECRO GAINESVILLE LLC	`cfbc443f908e1b65d8bd295563ea58da42768a483239b2a9982d4dd36c8c5122`
1414	A	087371	001	PHENDIMETRAZINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	X-TROZINE L.A.	SHIRE RICHWOOD	105MG		[]	1982-08-24	Aug 24, 1982	No	No	No	DISCN	SHIRE RICHWOOD INC	`e0c589461b28930c713b5bb7ffcc4f22bd9a65940b1eac6f37c2e6f72675888f`
1415	N	201922	001	MINOCYCLINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	XIMINO	JOURNEY	EQ 45MG BASE		[]	2012-07-11	Jul 11, 2012	No	No	No	RX	JOURNEY MEDICAL CORP	`287057f00be8150300e5082051abb41ee3f490fcb48be6efd1b8bb3ab1ef9394`
1416	N	201922	002	MINOCYCLINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	XIMINO	JOURNEY	EQ 67.5MG BASE		[]	2012-07-11	Jul 11, 2012	No	No	No	DISCN	JOURNEY MEDICAL CORP	`b36fb16a183ebdbaf0f77dd68d42591ed1dc6defecc09e877e529820eef5bd5a`
1417	N	201922	003	MINOCYCLINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	XIMINO	JOURNEY	EQ 90MG BASE		[]	2012-07-11	Jul 11, 2012	No	No	No	RX	JOURNEY MEDICAL CORP	`9e6bf142e27b12e3eba544d256612a6e8326ef4745ade6dcd62f2c2428f830a9`
1418	N	201922	004	MINOCYCLINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	XIMINO	JOURNEY	EQ 112.5MG BASE		[]	2012-07-11	Jul 11, 2012	No	No	No	DISCN	JOURNEY MEDICAL CORP	`4f77288cc8308c0e5eec1f6fe0fd2d1a1e149544239dc891b9222da386fdbbc7`
1419	N	201922	005	MINOCYCLINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	XIMINO	JOURNEY	EQ 135MG BASE		[]	2012-07-11	Jul 11, 2012	No	No	No	RX	JOURNEY MEDICAL CORP	`08c124ad2e713e241dce390502eb0451796827989bfd00f17bd840be350efb7d`
1420	N	208090	001	OXYCODONE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	XTAMPZA ER	COLLEGIUM PHARM INC	9MG		[]	2016-04-26	Apr 26, 2016	No	Yes	No	RX	COLLEGIUM PHARMACEUTICAL INC	`e52d7be5d97840c93e766cf098c599e4fa192d806794b4a6c6647325073413a9`
1421	N	208090	002	OXYCODONE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	XTAMPZA ER	COLLEGIUM PHARM INC	13.5MG		[]	2016-04-26	Apr 26, 2016	No	Yes	No	RX	COLLEGIUM PHARMACEUTICAL INC	`5000618111d39c756dbfdc53c5fed5da600055a233f0f707b9cffa383cd03c47`
1422	N	208090	003	OXYCODONE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	XTAMPZA ER	COLLEGIUM PHARM INC	18MG		[]	2016-04-26	Apr 26, 2016	No	Yes	No	RX	COLLEGIUM PHARMACEUTICAL INC	`3cd81ad82556d5175905c6f60a5496af68449883f5fef0df1f8c4920e4edda1f`
1423	N	208090	004	OXYCODONE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	XTAMPZA ER	COLLEGIUM PHARM INC	27MG		[]	2016-04-26	Apr 26, 2016	No	Yes	No	RX	COLLEGIUM PHARMACEUTICAL INC	`0b6c3f0680baa450449d2715da3999ffad5c760d39e76503e1ac88a2561f9f4b`
1424	N	208090	005	OXYCODONE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	XTAMPZA ER	COLLEGIUM PHARM INC	36MG		[]	2016-04-26	Apr 26, 2016	No	Yes	Yes	RX	COLLEGIUM PHARMACEUTICAL INC	`5433b05fd32383764a22e3dd64672e1afcea89ab20c30efe9aa06e31157f196b`
1425	N	021453	001	STAVUDINE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	ZERIT XR	BRISTOL MYERS SQUIBB	37.5MG		[]	2002-12-31	Dec 31, 2002	No	No	No	DISCN	BRISTOL MYERS SQUIBB CO	`a4e785d4425e60cd1766d67b300fc76a982a5e980a6a153b0b45e579f6e4f5be`
1426	N	021453	002	STAVUDINE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	ZERIT XR	BRISTOL MYERS SQUIBB	50MG		[]	2002-12-31	Dec 31, 2002	No	No	No	DISCN	BRISTOL MYERS SQUIBB CO	`410177c86991762214b141d78c2439603e6b4442b38bc2940545615dd354c373`
1427	N	021453	003	STAVUDINE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	ZERIT XR	BRISTOL MYERS SQUIBB	75MG		[]	2002-12-31	Dec 31, 2002	No	No	No	DISCN	BRISTOL MYERS SQUIBB CO	`5bfe0812581f888c052abffc47c1c5dcbd53fc75b541ff606b9d5dc9273f96bf`
1428	N	021453	004	STAVUDINE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	ZERIT XR	BRISTOL MYERS SQUIBB	100MG		[]	2002-12-31	Dec 31, 2002	No	No	No	DISCN	BRISTOL MYERS SQUIBB CO	`f8d16c2742e59067e41f461ac42a69484534c0b2c89ea02aa791b8e2b16ad693`
1429	N	202880	001	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	ZOHYDRO ER	PERSION	10MG	AB	["AB"]	2013-10-25	Oct 25, 2013	No	Yes	Yes	RX	PERSION PHARMACEUTICALS LLC	`7a58816007e85ed9621e6f4a681da99cbd005c373ac5264474dce8999eb097fe`
1430	N	202880	002	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	ZOHYDRO ER	PERSION	15MG	AB	["AB"]	2013-10-25	Oct 25, 2013	No	Yes	No	RX	PERSION PHARMACEUTICALS LLC	`485b5346560949e4930ed8f0daf40ceb9248124fcc8c92209ada27706a5cc18e`
1431	N	202880	003	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	ZOHYDRO ER	PERSION	20MG	AB	["AB"]	2013-10-25	Oct 25, 2013	No	Yes	No	RX	PERSION PHARMACEUTICALS LLC	`fb564a331bbc5c0dc7673f9fdab84ac2db2e351d1cc3c54261234a1055bb0b74`
1432	N	202880	004	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	ZOHYDRO ER	PERSION	30MG	AB	["AB"]	2013-10-25	Oct 25, 2013	No	Yes	No	RX	PERSION PHARMACEUTICALS LLC	`5c7f86d4254e15faa77546ed54c964fa43fd281080ec1df0bc4fb2e0ab35d676`
1433	N	202880	005	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	ZOHYDRO ER	PERSION	40MG	AB	["AB"]	2013-10-25	Oct 25, 2013	No	Yes	No	RX	PERSION PHARMACEUTICALS LLC	`33e767e93afe11d1dca44f9b221bc3813b4263f176e821f0155a642d553acc18`
1434	N	202880	006	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	ZOHYDRO ER	PERSION	50MG	AB	["AB"]	2013-10-25	Oct 25, 2013	No	Yes	No	RX	PERSION PHARMACEUTICALS LLC	`89cb483d77a8053938197b5392e7c23abd3f8f3f26ce771266664774fd039cef`
1435	N	210709	001	ALISKIREN HEMIFUMARATE	CAPSULE, PELLET;ORAL	CAPSULE, PELLET	ORAL	TEKTURNA	NODEN PHARMA	EQ 37.5MG BASE		[]	2017-11-14	Nov 14, 2017	No	Yes	No	DISCN	NODEN PHARMA DAC	`22981a56fedb4ca6e216ba47bf7ccec24f1a4c8cba4e968534549d5d2143f216`
1436	N	050824	001	AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE	ORAL	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	CUMBERLAND PHARMS	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG		[]	2011-02-08	Feb 8, 2011	No	Yes	Yes	RX	CUMBERLAND PHARMACEUTICALS INC	`d142248cd4739972a2e421d7c7e2c29511cbc1c3495842903a61fe446392bb8e`
1437	N	016990	001	CROMOLYN SODIUM	CAPSULE;INHALATION	CAPSULE	INHALATION	INTAL	SANOFI AVENTIS US	20MG 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	SANOFI AVENTIS US LLC	`58718521fc2f4db89d7407f438b710a3c74e77ef3d54c97c50d07fae0a87613e`
1438	N	019489	001	ALBUTEROL SULFATE	CAPSULE;INHALATION	CAPSULE	INHALATION	VENTOLIN ROTACAPS	GLAXOSMITHKLINE	EQ 0.2MG BASE		[]	1988-05-04	May 4, 1988	No	No	No	DISCN	GLAXOSMITHKLINE	`5b6a0740d007728b722f8c584d7136d8f8b2bc75aa7da1b207c9386be95bb8c8`
1439	N	009048	001	METHOXSALEN	CAPSULE;ORAL	CAPSULE	ORAL	8-MOP	VALEANT PHARM INTL	10MG		[]		Approved Prior to Jan 1, 1982	Yes	Yes	No	DISCN	VALEANT PHARMACEUTICALS INTERNATIONAL	`18fb773e10df0c1bc47e8feafc4b3e1beae8e649d8f6f91d895221f4d79b51be`
1440	A	085447	001	CHLORDIAZEPOXIDE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	A-POXIDE	ABBOTT	5MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV	`d2c89335cb20623128b64037995792430e0d0c17f38afd5fedae6a9235d127c3`
1441	A	085517	001	CHLORDIAZEPOXIDE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	A-POXIDE	ABBOTT	5MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV	`75a36be08cf5c9d2d4ee7f27e6e8ddc2caab5c9376e886c68d6953b108b5ceb5`
1442	A	085447	002	CHLORDIAZEPOXIDE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	A-POXIDE	ABBOTT	10MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV	`41353f76c527000cf22104f3f2f63ba21d7df0e34f8246d2d064402566f13218`
1443	A	085518	001	CHLORDIAZEPOXIDE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	A-POXIDE	ABBOTT	10MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV	`b14f643c7b38e6f254331e6a6d3ea1e1743fd8b35d7ee3c4778b7ab055cf4dde`
1444	A	085447	003	CHLORDIAZEPOXIDE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	A-POXIDE	ABBOTT	25MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV	`30d716bf1036c697ce69b94cf35d8d22c02a910a5a84afe86dd328b7ee9ef161`
1445	A	085513	001	CHLORDIAZEPOXIDE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	A-POXIDE	ABBOTT	25MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV	`ed5eb46fba78846ede4decb641e7e5590f9b24f37c9031ecfa8b3d4a9d2da771`
1446	N	021951	001	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ABSORICA	SUN PHARM INDS INC	10MG	AB2	["AB2"]	2012-05-25	May 25, 2012	No	Yes	No	RX	SUN PHARMACEUTICAL INDUSTRIES INC	`64c40c6274fcb0c54bfc4955d56c20284a5dff70c4acefc9e66387644971c3da`
1447	N	021951	002	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ABSORICA	SUN PHARM INDS INC	20MG	AB2	["AB2"]	2012-05-25	May 25, 2012	No	Yes	No	RX	SUN PHARMACEUTICAL INDUSTRIES INC	`f1d6ad04982fe3619f37c97d1c2d6dcec446c5a61ddec129b582ea8517b7e59c`
1448	N	021951	005	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ABSORICA	SUN PHARM INDS INC	25MG	AB2	["AB2"]	2014-08-15	Aug 15, 2014	No	Yes	No	RX	SUN PHARMACEUTICAL INDUSTRIES INC	`27d0cfd9c7015cf67903f53f5a7b6f4f23f1aa22ac16dd75c93ec78b84077214`
1449	N	021951	003	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ABSORICA	SUN PHARM INDS INC	30MG	AB2	["AB2"]	2012-05-25	May 25, 2012	No	Yes	No	RX	SUN PHARMACEUTICAL INDUSTRIES INC	`19abbf6df35338541c20438a9fc8053e9f6f450e28e3875ae1c281ca5c47d3bd`
1450	N	021951	006	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ABSORICA	SUN PHARM INDS INC	35MG	AB2	["AB2"]	2014-08-15	Aug 15, 2014	No	Yes	No	RX	SUN PHARMACEUTICAL INDUSTRIES INC	`db960f601e5f435a3bcdc6d7704bea728407518794f8645120fab790be088766`
1451	N	021951	004	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ABSORICA	SUN PHARM INDS INC	40MG	AB2	["AB2"]	2012-05-25	May 25, 2012	No	Yes	Yes	RX	SUN PHARMACEUTICAL INDUSTRIES INC	`aa5e595f7ef811131ad9552bbd939a0f95144ddbd6982badf63f8f2ee90d5b0b`