Orange Book snapshot 21: Products

Products page 30 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
1452	N	211913	001	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ABSORICA LD	SUN PHARM	8MG		[]	2019-11-05	Nov 5, 2019	No	Yes	No	RX	SUN PHARMACEUTICAL INDUSTRIES LTD	`50ce7f959f9158086d8e41eadb1113b02b92acceeabf5bc8d9e462f20543f9c0`
1453	N	211913	002	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ABSORICA LD	SUN PHARM	16MG		[]	2019-11-05	Nov 5, 2019	No	Yes	No	RX	SUN PHARMACEUTICAL INDUSTRIES LTD	`aafc49ff8408a7572903168343610460d77a31e305e84f4700a3643d599d6bfb`
1454	N	211913	003	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ABSORICA LD	SUN PHARM	20MG		[]	2019-11-05	Nov 5, 2019	No	Yes	No	DISCN	SUN PHARMACEUTICAL INDUSTRIES LTD	`9f017c2710627d3225b8d3366d9f2473177f9865883c3f32dc7238d41bc20b10`
1455	N	211913	004	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ABSORICA LD	SUN PHARM	24MG		[]	2019-11-05	Nov 5, 2019	No	Yes	No	RX	SUN PHARMACEUTICAL INDUSTRIES LTD	`031f9d9dba7aa62b504007746e617da9dcd6bb252ad0d23fa757050f42adaa1d`
1456	N	211913	005	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ABSORICA LD	SUN PHARM	28MG		[]	2019-11-05	Nov 5, 2019	No	Yes	No	DISCN	SUN PHARMACEUTICAL INDUSTRIES LTD	`1d30eeb4a06953c4607f9a9aff8916452c6fb89d8734d4455240856f00e3ac41`
1457	N	211913	006	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ABSORICA LD	SUN PHARM	32MG		[]	2019-11-05	Nov 5, 2019	No	Yes	Yes	RX	SUN PHARMACEUTICAL INDUSTRIES LTD	`32a780e9e76bc9b5e03837ee07518b693ca3676fdc69d6330f2d2e8d3c33efc5`
1458	N	212320	001	FERRIC MALTOL	CAPSULE;ORAL	CAPSULE	ORAL	ACCRUFER	SHIELD TX	30MG IRON		[]	2019-07-25	Jul 25, 2019	No	Yes	No	DISCN	SHIELD TX UK LTD	`9fbf339586c1380a0ad68797821bc95f5866f44a31ae430f2cfa56793675db5d`
1459	N	018662	002	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ACCUTANE	HOFFMANN LA ROCHE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1982-05-07	May 7, 1982	No	Yes	No	DISCN	HOFFMANN LA ROCHE INC	`76f3baf886dc147209a5e529c961d65818555be2e3ee233ebc239a0b70f5dc65`
1460	N	018662	004	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ACCUTANE	HOFFMANN LA ROCHE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1983-03-28	Mar 28, 1983	No	Yes	No	DISCN	HOFFMANN LA ROCHE INC	`1a6fb01c8617581d0198e428592def6dcba76b61ab5677a31a8bfa0f0d2a5bec`
1461	N	018662	003	ISOTRETINOIN	CAPSULE;ORAL	CAPSULE	ORAL	ACCUTANE	HOFFMANN LA ROCHE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1982-05-07	May 7, 1982	No	Yes	No	DISCN	HOFFMANN LA ROCHE INC	`736bbbbe9f2f27e7d157029fd32b11fd18167675a1819e2df4ac248f66d6424d`
1462	A	075047	001	ACEBUTOLOL HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	ACEBUTOLOL HYDROCHLORIDE	AMNEAL PHARM	EQ 200MG BASE	AB	["AB"]	1999-12-30	Dec 30, 1999	No	No	Yes	RX	AMNEAL PHARMACEUTICAL	`72728a21e5dd2452d44b271ddc6869f7b6853a7e4514c83a50318cddf207235c`
1463	A	075047	002	ACEBUTOLOL HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	ACEBUTOLOL HYDROCHLORIDE	AMNEAL PHARM	EQ 400MG BASE	AB	["AB"]	1999-12-30	Dec 30, 1999	No	No	Yes	RX	AMNEAL PHARMACEUTICAL	`599cd93f9d25a737a8cc77abcb018da8f3240de4bfb1761338f9bbd49c144a14`
1464	A	074007	001	ACEBUTOLOL HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	ACEBUTOLOL HYDROCHLORIDE	ANI PHARMS INC	EQ 200MG BASE		[]	1995-10-18	Oct 18, 1995	No	No	No	DISCN	ANI PHARMACEUTICALS INC	`d284a8cf889ae86012072d8e50b2bea5960df50d7bc8a248a288f81bb92b9762`
1465	A	074007	002	ACEBUTOLOL HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	ACEBUTOLOL HYDROCHLORIDE	ANI PHARMS INC	EQ 400MG BASE		[]	1995-10-18	Oct 18, 1995	No	No	No	DISCN	ANI PHARMACEUTICALS INC	`fe50fc8ef614e6cfb741ff7ae1fb8ee894eee43ab01321778f7805b7fe3cb739`
1466	A	074288	001	ACEBUTOLOL HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	ACEBUTOLOL HYDROCHLORIDE	MYLAN	EQ 200MG BASE	AB	["AB"]	1995-04-24	Apr 24, 1995	No	No	No	RX	MYLAN PHARMACEUTICALS INC	`c3b85938e2502054e819e1556e083d28f91775177492536bfc267841917c11ff`
1467	A	074288	002	ACEBUTOLOL HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	ACEBUTOLOL HYDROCHLORIDE	MYLAN	EQ 400MG BASE	AB	["AB"]	1995-04-24	Apr 24, 1995	No	No	No	RX	MYLAN PHARMACEUTICALS INC	`ad2eac2e9707fde0a4540d757a82be15b77595e7f903e1727c3de08fc91d2673`
1468	A	088537	001	ACETAMINOPHEN; CODEINE PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	ACETAMINOPHEN AND CODEINE PHOSPHATE	TEVA	300MG;15MG		[]	1984-06-04	Jun 4, 1984	No	No	No	DISCN	TEVA PHARMACEUTICALS USA INC	`b1edc62d3ba6f89bcf84a688aa32079a999c8717f528523b90e4aefedbb854d3`
1469	A	088324	001	ACETAMINOPHEN; CODEINE PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	ACETAMINOPHEN AND CODEINE PHOSPHATE	TEVA	300MG;30MG		[]	1983-12-29	Dec 29, 1983	No	No	No	DISCN	TEVA PHARMACEUTICALS USA INC	`62d0b4a7ef5ceced49f186951e4299aaa1e79eb821fd145587db88d1a4dae432`
1470	A	088599	001	ACETAMINOPHEN; CODEINE PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	ACETAMINOPHEN AND CODEINE PHOSPHATE	TEVA	300MG;60MG		[]	1984-06-01	Jun 1, 1984	No	No	No	DISCN	TEVA PHARMACEUTICALS USA INC	`c754c0efd98934aa623653ed6f19fc15e9f56e1e2a870efb99437c0eed37e738`
1471	A	088898	001	ACETAMINOPHEN; HYDROCODONE BITARTRATE	CAPSULE;ORAL	CAPSULE	ORAL	ACETAMINOPHEN AND HYDROCODONE BITARTRATE	CENT PHARMS	500MG;5MG		[]	1985-03-27	Mar 27, 1985	No	No	No	DISCN	CENTRAL PHARMACEUTICALS INC	`af5235f1d44ebb73f15ba93c7069feb18b3416f97c25d486ce71f422635250cd`
1472	A	081095	001	ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE	MIKART	150MG;180MG;15MG		[]	1990-10-26	Oct 26, 1990	No	No	No	DISCN	MIKART LLC	`f339b42f29073700460f4c96b1e6dec5bdde748d14562aec520acae8f93d888f`
1473	A	081096	001	ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE	MIKART	150MG;180MG;30MG		[]	1990-10-26	Oct 26, 1990	No	No	No	DISCN	MIKART LLC	`f4048950308e28efc4f133eb5e5caf122079270b160cf520e3e41a67634d5d71`
1474	A	081097	001	ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE	MIKART	150MG;180MG;60MG		[]	1990-10-26	Oct 26, 1990	No	No	No	DISCN	MIKART LLC	`a2e8de752714c28e6d80ab6c97166a526f4b2422dbd89e0afb9f09feacfeb8d0`
1475	A	040109	001	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE	CAPSULE;ORAL	CAPSULE	ORAL	ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE	MIKART	356.4MG;30MG;16MG		[]	1997-08-26	Aug 26, 1997	No	No	No	DISCN	MIKART LLC	`cdfc4e82fb0efdc5a083899c8186cef2f47494723d14449af6127a9b39b29d02`
1476	A	040688	001	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE	CAPSULE;ORAL	CAPSULE	ORAL	ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE	WRASER PHARMS LLC	356.4MG;30MG;16MG		[]	2007-04-03	Apr 3, 2007	No	No	No	DISCN	WRASER PHARMACEUTICALS LLC	`b72fa5bc951678ded3a7eab380b7479dc80aef50b003b5fa0f401f23bc83efcd`
1477	N	050278	003	TETRACYCLINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	ACHROMYCIN V	AVET	250MG	AB	["AB"]		Approved Prior to Jan 1, 1982	Yes	Yes	No	RX	AVET PHARMACEUTICALS INC	`e6772382d8bf307c56db0831ffbf6538e0286d54fa428d1c094177a4ab7f3514`
1478	N	050278	001	TETRACYCLINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	ACHROMYCIN V	AVET	500MG	AB	["AB"]		Approved Prior to Jan 1, 1982	Yes	Yes	Yes	RX	AVET PHARMACEUTICALS INC	`8dad857c35b84d2f915c480f5961392e40a3644814c540755a1aff197af91fe3`
1479	A	091455	001	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	BARR LABS INC	10MG	AB	["AB"]	2013-04-04	Apr 4, 2013	No	No	No	RX	BARR LABORATORIES INC	`a7387ea920902ce0bbfa233dbc3690b15e4b40e6affb3138111aa34dc90bc627`
1480	A	091455	002	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	BARR LABS INC	25MG	AB	["AB"]	2013-04-04	Apr 4, 2013	No	No	No	RX	BARR LABORATORIES INC	`51abf481ca4ff77594843946908ba5ac8a1843696068bac7db06bec0d873598a`
1481	A	202552	001	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	IMPAX LABS INC	10MG	AB	["AB"]	2015-12-23	Dec 23, 2015	No	No	No	RX	IMPAX LABORATORIES INC	`c181ddcae1195d2f9f7ef239ccab1e652bdaf6262ee6b3c21496af07f37bae53`
1482	A	202552	002	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	IMPAX LABS INC	17.5MG	AB	["AB"]	2015-12-23	Dec 23, 2015	No	No	No	RX	IMPAX LABORATORIES INC	`cf8b6f4faafc00c0fb00dfb42a034a0df0f94ec10a4144009687cae0d7752d90`
1483	A	202552	003	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	IMPAX LABS INC	22.5MG	AB	["AB"]	2015-12-23	Dec 23, 2015	No	No	No	RX	IMPAX LABORATORIES INC	`3d26a4f7b119e199639da0d9a556af18472ea29c89642f193902193283125137`
1484	A	202552	004	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	IMPAX LABS INC	25MG	AB	["AB"]	2015-12-23	Dec 23, 2015	No	No	No	RX	IMPAX LABORATORIES INC	`5f1908e4508859716c128a10c6692e6b61e6c0bb26f8683728266c0797d02dc9`
1485	A	202148	001	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	MYLAN	10MG	AB	["AB"]	2015-09-10	Sep 10, 2015	No	No	No	RX	MYLAN PHARMACEUTICALS INC	`8cd1bf8da11f3ffd84581d56466419c73639b09bb4d9d65808768f5c67f4c5f7`
1486	A	203707	001	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	MYLAN	17.5MG		[]	2015-09-10	Sep 10, 2015	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`f677d2a9c05e4a006199695d4285f8000a99d5e7e7a6ac03b2e25331765bde9c`
1487	A	203707	002	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	MYLAN	22.5MG		[]	2015-09-10	Sep 10, 2015	No	No	No	DISCN	MYLAN PHARMACEUTICALS INC	`dc14970b9308ac73643f0e93ebb530ca11fafb28fc08d9451cdb69e6dab0efbd`
1488	A	202148	002	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	MYLAN	25MG	AB	["AB"]	2015-09-10	Sep 10, 2015	No	No	No	RX	MYLAN PHARMACEUTICALS INC	`d86b14a159315aa2eb640c0eb355dfc0e3db98f87e9eedb039234cbfd9bfb31c`
1489	A	204633	001	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	SIGMAPHARM LABS LLC	10MG	AB	["AB"]	2015-05-22	May 22, 2015	No	No	No	RX	SIGMAPHARM LABORATORIES LLC	`28b7477ffbe5be4b1ed7797eef9ca9f21b98bafe043e07483c3c8c8236979516`
1490	A	204633	002	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	SIGMAPHARM LABS LLC	17.5MG	AB	["AB"]	2015-05-22	May 22, 2015	No	No	No	RX	SIGMAPHARM LABORATORIES LLC	`19ec6a9c55e37553b9d45ef8e899b617336efed7e5496de58221e9802d40e898`
1491	A	204633	003	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	SIGMAPHARM LABS LLC	22.5MG	AB	["AB"]	2015-05-22	May 22, 2015	No	No	No	RX	SIGMAPHARM LABORATORIES LLC	`9d2509b7202c494770d4fe6933efde0ddd0f4542a27f083db293d8b7b62da829`
1492	A	204633	004	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	SIGMAPHARM LABS LLC	25MG	AB	["AB"]	2015-05-22	May 22, 2015	No	No	No	RX	SIGMAPHARM LABORATORIES LLC	`82366a11f8f3e345f75cf8f369a585ef1eb5f25e8c29f6903c0296e7f01d68ae`
1493	A	202897	001	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	TEVA PHARMS USA	17.5MG	AB	["AB"]	2013-04-04	Apr 4, 2013	No	No	No	RX	TEVA PHARMACEUTICALS USA	`9ae9174927b03ae3617224e7f2caaa040123a2c4a4b3694b9cb6f1f1ee9f81d8`
1494	A	202897	002	ACITRETIN	CAPSULE;ORAL	CAPSULE	ORAL	ACITRETIN	TEVA PHARMS USA	22.5MG	AB	["AB"]	2013-04-04	Apr 4, 2013	No	No	No	RX	TEVA PHARMACEUTICALS USA	`10a07389e67981e5b3cad7e1bf09b0af98dce656619c2e9503bb86816e98d838`
1495	N	208253	001	DOXYCYCLINE HYCLATE	CAPSULE;ORAL	CAPSULE	ORAL	ACTICLATE CAP	ALMIRALL	EQ 75MG BASE		[]	2016-04-26	Apr 26, 2016	No	Yes	No	DISCN	ALMIRALL LLC	`3f299c1ff95cc7dba98f21effca569af01b1cf348cb8ad4e3c2e4983c6033f53`
1496	N	019594	001	URSODIOL	CAPSULE;ORAL	CAPSULE	ORAL	ACTIGALL	ALLERGAN	150MG		[]	1987-12-31	Dec 31, 1987	No	No	No	DISCN	ALLERGAN SALES LLC	`06351a041a4aa9c74a0cf84ad757a11c01d792e59a4fa372ab3bb995666618d7`
1497	N	019594	002	URSODIOL	CAPSULE;ORAL	CAPSULE	ORAL	ACTIGALL	ALLERGAN	300MG	AB	["AB"]	1987-12-31	Dec 31, 1987	No	Yes	Yes	RX	ALLERGAN SALES LLC	`cfe94f4a725476d0818ead31dfa95cf54d2209f4794f4e3efed8bde28465e7b0`
1498	A	074906	001	ACYCLOVIR	CAPSULE;ORAL	CAPSULE	ORAL	ACYCLOVIR	ACTAVIS ELIZABETH	200MG		[]	1997-08-26	Aug 26, 1997	No	No	No	DISCN	ACTAVIS ELIZABETH LLC	`53c5d3993c59ae4dcdd3889989cbb92f65408dae0b97701abb4db0db2add0661`
1499	A	075677	001	ACYCLOVIR	CAPSULE;ORAL	CAPSULE	ORAL	ACYCLOVIR	APOTEX	200MG	AB	["AB"]	2005-09-28	Sep 28, 2005	No	No	Yes	RX	APOTEX INC	`335128b1068f2db7c98366b40d49a70e7c099381680c15a7b19e7bd506de5ace`
1500	A	204313	001	ACYCLOVIR	CAPSULE;ORAL	CAPSULE	ORAL	ACYCLOVIR	CADILA	200MG	AB	["AB"]	2016-03-25	Mar 25, 2016	No	No	No	RX	CADILA HEALTHCARE LTD	`273cd6d80339583c786f29c40577aac73eb7b18534a9b587e426551d9b9a35cf`
1501	A	201445	001	ACYCLOVIR	CAPSULE;ORAL	CAPSULE	ORAL	ACYCLOVIR	CADILA PHARMS LTD	200MG	AB	["AB"]	2014-03-06	Mar 6, 2014	No	No	No	RX	CADILA PHARMACEUTICALS LTD	`b981804e65579b591c9d6ce671c5907d5b922dd9e9814dfedf96357f6e8e9d26`