Orange Book snapshot 21: Products

Products page 70 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
3452	N	020628	001	SAQUINAVIR MESYLATE	CAPSULE;ORAL	CAPSULE	ORAL	INVIRASE	HOFFMANN LA ROCHE	EQ 200MG BASE		[]	1995-12-06	Dec 6, 1995	No	Yes	No	DISCN	HOFFMANN LA ROCHE INC	`b540af6e79e38e89ff3b6a07451be6021c9e6cab4d0f73c8baf7729ed0567d1e`
3453	N	010929	001	SODIUM IODIDE I-131	CAPSULE;ORAL	CAPSULE	ORAL	IODOTOPE	BRACCO	1-130mCi		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	BRACCO DIAGNOSTICS INC	`71ac5bd10c3bd8f4eda6bd9b9c7ebef0280e788ff3391fd250f93ad29ffc10fc`
3454	N	010929	003	SODIUM IODIDE I-131	CAPSULE;ORAL	CAPSULE	ORAL	IODOTOPE	BRACCO	1-150mCi		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	BRACCO DIAGNOSTICS INC	`b455204127cdc38f36e0e98080fad2b939596c5cd32ba64677387c795a8c816d`
3455	A	205063	001	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ISOTRETINOIN	ACTAVIS LABS FL	10MG	AB2	["AB2"]	2021-03-31	Mar 31, 2021	No	No	No	RX	ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC	`f802467943c6c95668944729e595f7e1a8d36503812da79bbd7dbb50cd43cbc2`
3456	A	205063	002	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ISOTRETINOIN	ACTAVIS LABS FL	20MG	AB2	["AB2"]	2021-03-31	Mar 31, 2021	No	No	No	RX	ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC	`c457f371ae0cde51c4ffe396d761e262237d13d008c3b432dc501b5d9f7b9443`
3457	A	205063	003	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ISOTRETINOIN	ACTAVIS LABS FL	25MG	AB2	["AB2"]	2021-03-31	Mar 31, 2021	No	No	No	RX	ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC	`66ef3d079bbf0ab96651366c6b7a116deb719508d8cd9d7e0891412776f4737d`
3458	A	205063	004	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ISOTRETINOIN	ACTAVIS LABS FL	30MG	AB2	["AB2"]	2021-03-31	Mar 31, 2021	No	No	No	RX	ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC	`66cb0f7fb30e73db7d08505c4ea17b03e57e815095b745b9d5473acf198de2a2`
3459	A	205063	005	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ISOTRETINOIN	ACTAVIS LABS FL	35MG	AB2	["AB2"]	2021-03-31	Mar 31, 2021	No	No	No	RX	ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC	`09b00cb480787e8453acd8a4b065cfeb694e6ce972afde8285a34bffaf1f6f9d`
3460	A	205063	006	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ISOTRETINOIN	ACTAVIS LABS FL	40MG	AB2	["AB2"]	2021-03-31	Mar 31, 2021	No	No	No	RX	ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC	`66a1c4d58a9501bac2398c584f0e2088442dab76476477cd4c0cb0f866789169`
3461	A	207792	001	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ISOTRETINOIN	AMNEAL PHARMS NY	10MG	AB1	["AB1"]	2017-09-29	Sep 29, 2017	No	No	No	RX	AMNEAL PHARMACEUTICALS OF NY LLC	`d5a6fd886def0f8229398621ae784165af98d8d026e7e81a2ddca95325433fd7`
3462	A	207792	002	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ISOTRETINOIN	AMNEAL PHARMS NY	20MG	AB1	["AB1"]	2017-09-29	Sep 29, 2017	No	No	No	RX	AMNEAL PHARMACEUTICALS OF NY LLC	`3a5496479844d2b2f8997280dc703ab35989abea1e3bd812931f38bfe89e4ee3`
3463	A	207792	003	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ISOTRETINOIN	AMNEAL PHARMS NY	30MG	AB1	["AB1"]	2017-09-29	Sep 29, 2017	No	No	No	RX	AMNEAL PHARMACEUTICALS OF NY LLC	`bc914a9cb551055c2fa2cc08797ff8eeb912e475cc93059d934cda41fcb5e851`
3464	A	207792	004	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ISOTRETINOIN	AMNEAL PHARMS NY	40MG	AB1	["AB1"]	2017-09-29	Sep 29, 2017	No	No	No	RX	AMNEAL PHARMACEUTICALS OF NY LLC	`bf4f8d25595beec9e5d54fec9ddd2b04ed52c6a2dbb1980fac30b0f17fc23722`
3465	A	077169	001	ISRADIPINE	CAPSULE;ORAL	CAPSULE	ORAL	ISRADIPINE	ELITE LABS INC	2.5MG	AB	["AB"]	2006-04-24	Apr 24, 2006	No	No	No	RX	ELITE LABORATORIES INC	`2e93a19da1453171f14770233d478c0c453b53101aa0027b37aa97d89076fe19`
3466	A	077169	002	ISRADIPINE	CAPSULE;ORAL	CAPSULE	ORAL	ISRADIPINE	ELITE LABS INC	5MG	AB	["AB"]	2006-04-24	Apr 24, 2006	No	No	No	RX	ELITE LABORATORIES INC	`3a7a25b304bd36694d6a4807c4b58e48b8576359e4311c42ce6331542f6b64b1`
3467	A	077317	001	ISRADIPINE	CAPSULE;ORAL	CAPSULE	ORAL	ISRADIPINE	WATSON LABS TEVA	2.5MG	AB	["AB"]	2006-01-05	Jan 5, 2006	No	No	No	RX	WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC	`7847403b9b3d7a5dccdd91323fd77244c21c65252e85ee569e5d806a65c2649a`
3468	A	077317	002	ISRADIPINE	CAPSULE;ORAL	CAPSULE	ORAL	ISRADIPINE	WATSON LABS TEVA	5MG	AB	["AB"]	2006-01-05	Jan 5, 2006	No	No	Yes	RX	WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC	`aeca298183a92f5f3a7c771e4400bf15cd16ce93f528b7bd59861112383b4e38`
3469	A	205991	001	ITRACONAZOLE	CAPSULE;ORAL	CAPSULE	ORAL	ITRACONAZOLE	ACCORD HLTHCARE	100MG	AB	["AB"]	2016-05-26	May 26, 2016	No	No	No	RX	ACCORD HEALTHCARE INC	`671f467d3fe34146332f9f55a4569de77b70f6d78bb1bb38f0ab8212ff8b9d5d`
3470	A	206741	001	ITRACONAZOLE	CAPSULE;ORAL	CAPSULE	ORAL	ITRACONAZOLE	ALEMBIC PHARMS LTD	100MG	AB	["AB"]	2016-12-13	Dec 13, 2016	No	No	No	RX	ALEMBIC PHARMACEUTICALS LTD	`ae365c44945b202be6226ad53726b47a8c657266ab40f4cdf567594727f5df91`
3471	A	208591	001	ITRACONAZOLE	CAPSULE;ORAL	CAPSULE	ORAL	ITRACONAZOLE	ALKEM LABS LTD	100MG	AB	["AB"]	2017-06-12	Jun 12, 2017	No	No	No	RX	ALKEM LABORATORIES LTD	`481aeb5e20ce0454aaec5dff2266b19179017d66b5ab6cab9f36ccd5d06994ff`
3472	A	205080	001	ITRACONAZOLE	CAPSULE;ORAL	CAPSULE	ORAL	ITRACONAZOLE	AMNEAL PHARMS	100MG	AB	["AB"]	2016-09-26	Sep 26, 2016	No	No	No	RX	AMNEAL PHARMACEUTICALS	`122420e629d29bd0bcbb5eb16ab51b0b5b8e34cd61951276c9300d5c0b04cb35`
3473	A	203445	001	ITRACONAZOLE	CAPSULE;ORAL	CAPSULE	ORAL	ITRACONAZOLE	JUBILANT GENERICS	100MG	AB	["AB"]	2017-02-23	Feb 23, 2017	No	No	No	RX	JUBILANT GENERICS LTD	`be39a750ccc36ff503a1b82d5d2ec689f7c2d87740660c79ac765a696e000d64`
3474	A	200463	001	ITRACONAZOLE	CAPSULE;ORAL	CAPSULE	ORAL	ITRACONAZOLE	MYLAN PHARMS INC	100MG	AB	["AB"]	2012-07-20	Jul 20, 2012	No	No	No	RX	MYLAN PHARMACEUTICALS INC	`fd4c37babd8ff1c554dca61a54b6310eaaf92029fcb120b8c9371377d56d1347`
3475	A	205724	001	ITRACONAZOLE	CAPSULE;ORAL	CAPSULE	ORAL	ITRACONAZOLE	PAR PHARM INC	100MG	AB	["AB"]	2016-12-13	Dec 13, 2016	No	No	No	RX	PAR PHARMACEUTICAL INC	`ab89a9491b7ba5746e890b98ef5d72a3678367baed745fb501d459504899bb46`
3476	A	076104	001	ITRACONAZOLE	CAPSULE;ORAL	CAPSULE	ORAL	ITRACONAZOLE	SANDOZ	100MG	AB	["AB"]	2004-05-28	May 28, 2004	No	No	No	RX	SANDOZ INC	`e21bdb7ff3ace37e506fbeadbdedb4ae5aabd0799ee8c710407d9f9b231454ad`
3477	A	206410	001	ITRACONAZOLE	CAPSULE;ORAL	CAPSULE	ORAL	ITRACONAZOLE	STRIDES PHARMA	100MG	AB	["AB"]	2019-07-02	Jul 2, 2019	No	No	No	RX	STRIDES PHARMA GLOBAL PTE LTD	`395222356f69d1f39648ca1b1fdc1e6f3e95ce9f046c7524c923506ffc6a4955`
3478	A	209460	001	ITRACONAZOLE	CAPSULE;ORAL	CAPSULE	ORAL	ITRACONAZOLE	TORRENT	100MG	AB	["AB"]	2018-08-24	Aug 24, 2018	No	No	No	RX	TORRENT PHARMACEUTICALS LTD	`0dc53f0dcb0b3b3606cb1d7643f2dd96bd51024af0c2d927693d76ac2468809b`
3479	A	204672	001	ITRACONAZOLE	CAPSULE;ORAL	CAPSULE	ORAL	ITRACONAZOLE	ZYDUS PHARMS	100MG	AB	["AB"]	2017-09-19	Sep 19, 2017	No	No	No	RX	ZYDUS PHARMACEUTICALS USA INC	`b333e2c2f45037d3171182237501abceff508284c3a81bad1f4bd8390c193d9e`
3480	N	022460	001	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	JALYN	GLAXOSMITHKLINE	0.5MG;0.4MG	AB	["AB"]	2010-06-14	Jun 14, 2010	No	Yes	Yes	RX	GLAXOSMITHKLINE	`2a9dbfd6ce2cf01169014ed4224e77165cbd5617bf1446eae5e1a49e47727da1`
3481	N	206089	001	TESTOSTERONE UNDECANOATE	CAPSULE;ORAL	CAPSULE	ORAL	JATENZO	CLARUS	158MG		[]	2019-03-27	Mar 27, 2019	No	Yes	No	RX	CLARUS THERAPEUTICS INC	`faa26f479172383fb3f586bcc2735583a7659f6534bdbf922368f815c63e9ede`
3482	N	206089	002	TESTOSTERONE UNDECANOATE	CAPSULE;ORAL	CAPSULE	ORAL	JATENZO	CLARUS	198MG		[]	2019-03-27	Mar 27, 2019	No	Yes	No	RX	CLARUS THERAPEUTICS INC	`35dd22d773eb153304aed223265c1348aec44326449cf984adfa395b1220a7c9`
3483	N	206089	003	TESTOSTERONE UNDECANOATE	CAPSULE;ORAL	CAPSULE	ORAL	JATENZO	CLARUS	237MG		[]	2019-03-27	Mar 27, 2019	No	Yes	Yes	RX	CLARUS THERAPEUTICS INC	`79693a74de6a9a9768751b17ddbaf712715f5e84117793b26f7a795f5942b0c4`
3484	N	203858	001	LOMITAPIDE MESYLATE	CAPSULE;ORAL	CAPSULE	ORAL	JUXTAPID	AMRYT	EQ 5MG BASE		[]	2012-12-21	Dec 21, 2012	No	Yes	No	RX	AMRYT PHARMACEUTICALS DAC	`8158e7a6516e8d3647b1bdfb077067e4f10aaf6c786aff76f93a5f13fc366b5f`
3485	N	203858	002	LOMITAPIDE MESYLATE	CAPSULE;ORAL	CAPSULE	ORAL	JUXTAPID	AMRYT	EQ 10MG BASE		[]	2012-12-21	Dec 21, 2012	No	Yes	No	RX	AMRYT PHARMACEUTICALS DAC	`c84d6152b05386264fcb28d0f4e145d06d2ccfcb33027561b24d743455007b2a`
3486	N	203858	003	LOMITAPIDE MESYLATE	CAPSULE;ORAL	CAPSULE	ORAL	JUXTAPID	AMRYT	EQ 20MG BASE		[]	2012-12-21	Dec 21, 2012	No	Yes	No	RX	AMRYT PHARMACEUTICALS DAC	`6501b160ca292dd602f72014835eba4c960543d53ce246874b768f5b5cd5990d`
3487	N	203858	004	LOMITAPIDE MESYLATE	CAPSULE;ORAL	CAPSULE	ORAL	JUXTAPID	AMRYT	EQ 30MG BASE		[]	2015-04-23	Apr 23, 2015	No	Yes	No	RX	AMRYT PHARMACEUTICALS DAC	`4322322cf8840bd97d33afff86cdbf1fb9d3023707cb7b33524f2e77407069cd`
3488	N	203858	005	LOMITAPIDE MESYLATE	CAPSULE;ORAL	CAPSULE	ORAL	JUXTAPID	AMRYT	EQ 40MG BASE		[]	2015-04-23	Apr 23, 2015	No	Yes	No	DISCN	AMRYT PHARMACEUTICALS DAC	`f95d9617ac13fbdfb4da92f9416d273baac0ad3adad51bc1cad2d99c856b351f`
3489	N	203858	006	LOMITAPIDE MESYLATE	CAPSULE;ORAL	CAPSULE	ORAL	JUXTAPID	AMRYT	EQ 60MG BASE		[]	2015-04-23	Apr 23, 2015	No	Yes	No	DISCN	AMRYT PHARMACEUTICALS DAC	`7147e82900376920b6811c4c20030cea91a4460833e2469257c9dbdbf63e8f90`
3490	N	050219	001	CEPHALOGLYCIN	CAPSULE;ORAL	CAPSULE	ORAL	KAFOCIN	LILLY	250MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	ELI LILLY AND CO	`d830aae13849dd597802c2609c57f3cdf9ef29c2660e3b5f599bc010e605eb12`
3491	N	021226	001	LOPINAVIR; RITONAVIR	CAPSULE;ORAL	CAPSULE	ORAL	KALETRA	ABBVIE	133.3MG;33.3MG		[]	2000-09-15	Sep 15, 2000	No	No	No	DISCN	ABBVIE INC	`0a1412433532ec453a3d332eefea9a56bbfe388abc12eeef9c0e895f6e8557dd`
3492	A	060516	001	KANAMYCIN SULFATE	CAPSULE;ORAL	CAPSULE	ORAL	KANTREX	APOTHECON	EQ 500MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	APOTHECON INC DIV BRISTOL MYERS SQUIBB	`69b2e7cf86d169c3d4b8f695d13bb4cb3825b85abb036215b7e39f960a2b6820`
3493	A	061911	001	KANAMYCIN SULFATE	CAPSULE;ORAL	CAPSULE	ORAL	KANTREX	APOTHECON	EQ 500MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	APOTHECON INC DIV BRISTOL MYERS SQUIBB	`1f93b43abcebc37fb55c5378ffdcf817ac770bd5af6d6a6312eb18c2ca8b5de3`
3494	A	062726	001	KANAMYCIN SULFATE	CAPSULE;ORAL	CAPSULE	ORAL	KANTREX	APOTHECON	EQ 500MG BASE		[]	1987-03-06	Mar 6, 1987	No	No	No	DISCN	APOTHECON INC DIV BRISTOL MYERS SQUIBB	`9153e93635570328914802b638bec0568c659394a2807bd96fc6e9f383d7ed78`
3495	N	050405	002	CEPHALEXIN	CAPSULE;ORAL	CAPSULE	ORAL	KEFLEX	PRAGMA	EQ 250MG BASE	AB	["AB"]		Approved Prior to Jan 1, 1982	Yes	Yes	No	RX	PRAGMA PHARMACEUTICALS LLC	`0b5d9bbac8053b479f9d1fe4e4b91041083c01a40086f08b5e5831b5c2154b09`
3496	N	050405	004	CEPHALEXIN	CAPSULE;ORAL	CAPSULE	ORAL	KEFLEX	PRAGMA	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	2006-05-12	May 12, 2006	No	Yes	No	DISCN	PRAGMA PHARMACEUTICALS LLC	`417dea85f9581f366f2a06cebd7e654fbf5009685a427c9798c0e1a0f3478a41`
3497	N	050405	003	CEPHALEXIN	CAPSULE;ORAL	CAPSULE	ORAL	KEFLEX	PRAGMA	EQ 500MG BASE	AB	["AB"]		Approved Prior to Jan 1, 1982	Yes	Yes	No	RX	PRAGMA PHARMACEUTICALS LLC	`bb1447f127f280bf84f4067f54fd6b88720837bbad8461150fc1faffb78d936b`
3498	N	050405	005	CEPHALEXIN	CAPSULE;ORAL	CAPSULE	ORAL	KEFLEX	PRAGMA	EQ 750MG BASE	AB	["AB"]	2006-05-12	May 12, 2006	No	Yes	Yes	RX	PRAGMA PHARMACEUTICALS LLC	`ddee5225520c6f5d1a1421bf5d12cd68998993b8ae0be2c300bca2d0eb371083`
3499	A	083544	001	PROPOXYPHENE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	KESSO-GESIC	MK LABS	65MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	MK LABORATORIES INC	`cb5dfa9a33150cfb75442847223346109e5318a15f6dd7f5df277db5542e0db0`
3500	A	074014	001	KETOPROFEN	CAPSULE;ORAL	CAPSULE	ORAL	KETOPROFEN	HERITAGE PHARMS INC	25MG		[]	1993-01-29	Jan 29, 1993	No	No	No	RX	HERITAGE PHARMACEUTICALS INC	`10b4fe974983d2b621504e81a90029a24e40515ad633230e983498ae284bb6cc`
3501	A	074014	002	KETOPROFEN	CAPSULE;ORAL	CAPSULE	ORAL	KETOPROFEN	HERITAGE PHARMS INC	50MG	AB	["AB"]	1993-01-29	Jan 29, 1993	No	No	No	RX	HERITAGE PHARMACEUTICALS INC	`7386b2287dbe595ac99e212457501c3b7fd3cf63cd3cb1af000a2874ebd12795`