Orange Book snapshot 21: Products

Products page 39 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
1902	A	075351	001	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	VINTAGE PHARMS LLC	325MG;50MG;40MG;30MG		[]	1999-03-05	Mar 5, 1999	No	No	No	DISCN	VINTAGE PHARMACEUTICALS LLC	`cca6469ccf6b8d7537c51a89b8db334e005c000ce56faef694caca08ba03a588`
1903	A	074359	001	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	CAPSULE;ORAL	CAPSULE	ORAL	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	WATSON LABS	325MG;50MG;40MG;30MG		[]	1995-08-31	Aug 31, 1995	No	No	No	DISCN	WATSON LABORATORIES INC	`dcdcfbdfae061b5c4d49efcf0772cc08fa7c373b48aa52132e71d581f9280b11`
1904	N	008319	009	PHENYLBUTAZONE	CAPSULE;ORAL	CAPSULE	ORAL	BUTAZOLIDIN	NOVARTIS	100MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	NOVARTIS PHARMACEUTICALS CORP	`06165ccd9cc02a82bd80e741d828c2370dccdef6b83e3613f09265d96112f867`
1905	A	085381	001	BUTABARBITAL SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	BUTICAPS	MEDPOINTE PHARM HLC	15MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	MEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INC	`a7026d1cbcc65dd6aa88fd841af1de05873697fa56e2e5aaa9e6a1b13fa018b7`
1906	A	085381	002	BUTABARBITAL SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	BUTICAPS	MEDPOINTE PHARM HLC	30MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	MEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INC	`1dc55f03063498722d1670e1324fb7fd06c42e4380fc28156a70b5ed24b0208e`
1907	A	085381	003	BUTABARBITAL SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	BUTICAPS	MEDPOINTE PHARM HLC	50MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	MEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INC	`0e193bd72e3cb1a9e0cd642615277c75f81258ebbac06480dd091c57180f3abf`
1908	A	085381	004	BUTABARBITAL SODIUM	CAPSULE;ORAL	CAPSULE	ORAL	BUTICAPS	MEDPOINTE PHARM HLC	100MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	MEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INC	`00191686f7d3f4b8e0558319e89743286168cca844bc99da3a026328a124de42`
1909	A	203289	002	CALCITRIOL	CAPSULE;ORAL	CAPSULE	ORAL	CALCITRIOL	AMNEAL PHARMS	0.25MCG	AB	["AB"]	2017-06-14	Jun 14, 2017	No	No	No	RX	AMNEAL PHARMACEUTICALS	`efd8e160b3769251ffa813dd46754d22da9c808993a78875f5f5dba94db3ff7d`
1910	A	203289	001	CALCITRIOL	CAPSULE;ORAL	CAPSULE	ORAL	CALCITRIOL	AMNEAL PHARMS	0.5MCG	AB	["AB"]	2017-06-14	Jun 14, 2017	No	No	No	RX	AMNEAL PHARMACEUTICALS	`11c3fb2ceea7c80183fb178b27a31b906eb015cbd87ad2d32bfcd0ee67cd7b5e`
1911	A	091174	001	CALCITRIOL	CAPSULE;ORAL	CAPSULE	ORAL	CALCITRIOL	BIONPHARMA INC	0.25MCG	AB	["AB"]	2013-05-24	May 24, 2013	No	No	No	RX	BIONPHARMA INC	`9dea38c434fdce6ff3ca45c53fae2c558633df06cf5bb0027acc158889cf07a2`
1912	A	091174	002	CALCITRIOL	CAPSULE;ORAL	CAPSULE	ORAL	CALCITRIOL	BIONPHARMA INC	0.5MCG	AB	["AB"]	2013-05-24	May 24, 2013	No	No	No	RX	BIONPHARMA INC	`5e3ab29d964a3d0657d037a1047ef3a1be05809d6076df505d76a5836b3fdf16`
1913	A	076917	001	CALCITRIOL	CAPSULE;ORAL	CAPSULE	ORAL	CALCITRIOL	HIKMA	0.25MCG	AB	["AB"]	2006-03-27	Mar 27, 2006	No	No	No	RX	HIKMA PHARMACEUTICALS USA INC	`f9c9231728b360a8a93c563f8dce4cfe328da7ba794b5b889c160b02671b8557`
1914	A	091356	001	CALCITRIOL	CAPSULE;ORAL	CAPSULE	ORAL	CALCITRIOL	STRIDES PHARMA	0.25MCG	AB	["AB"]	2014-12-12	Dec 12, 2014	No	No	No	RX	STRIDES PHARMA GLOBAL PTE LTD	`3a25b50c69d612524e7dfd814d0fa59a1da9522de46ead0126246317acef9e45`
1915	A	091356	002	CALCITRIOL	CAPSULE;ORAL	CAPSULE	ORAL	CALCITRIOL	STRIDES PHARMA	0.5MCG	AB	["AB"]	2014-12-12	Dec 12, 2014	No	No	No	RX	STRIDES PHARMA GLOBAL PTE LTD	`4f68c34949486834ce578bb20911ee97a9b36a8b8b4599c9c32428b350d1560a`
1916	A	204556	001	CALCITRIOL	CAPSULE;ORAL	CAPSULE	ORAL	CALCITRIOL	SUN PHARM	0.25MCG	AB	["AB"]	2019-02-21	Feb 21, 2019	No	No	No	RX	SUN PHARMACEUTICAL INDUSTRIES LTD	`6eb72350e38060d020dac13375f398438e6a67e1c992f8e24ae402ee4904a56f`
1917	A	204556	002	CALCITRIOL	CAPSULE;ORAL	CAPSULE	ORAL	CALCITRIOL	SUN PHARM	0.5MCG	AB	["AB"]	2019-02-21	Feb 21, 2019	No	No	No	RX	SUN PHARMACEUTICAL INDUSTRIES LTD	`8f8e5448acbf4e3a2cb75176e5c2df77782d4fe053b1d513ad1f612aa84ed17c`
1918	A	075765	001	CALCITRIOL	CAPSULE;ORAL	CAPSULE	ORAL	CALCITRIOL	TEVA	0.25MCG	AB	["AB"]	2001-10-12	Oct 12, 2001	No	No	No	RX	TEVA PHARMACEUTICALS USA INC	`7958da1ef9dbff532cd4caf72abb74f31e22a05a88338a84b7d881e67088d1ad`
1919	A	075765	002	CALCITRIOL	CAPSULE;ORAL	CAPSULE	ORAL	CALCITRIOL	TEVA	0.5MCG	AB	["AB"]	2001-10-12	Oct 12, 2001	No	No	No	RX	TEVA PHARMACEUTICALS USA INC	`6aaad24a6fc28fefaa985e79b39cc009a415b84344fdeacc5e890447571537f2`
1920	A	201658	001	CALCIUM ACETATE	CAPSULE;ORAL	CAPSULE	ORAL	CALCIUM ACETATE	AMNEAL PHARMS	667MG	AB	["AB"]	2014-10-06	Oct 6, 2014	No	No	No	RX	AMNEAL PHARMACEUTICALS	`0172dbb4a64dcea3bf8032c57287d275c15c72df37812d237df506639edc95e8`
1921	A	091312	001	CALCIUM ACETATE	CAPSULE;ORAL	CAPSULE	ORAL	CALCIUM ACETATE	CHARTWELL RX	667MG	AB	["AB"]	2012-06-01	Jun 1, 2012	No	No	No	RX	CHARTWELL RX SCIENCES LLC	`350f4e3826dadb10d1be0a490e8fbad51c62677603365ed46fcdd6c39823734e`
1922	A	202315	001	CALCIUM ACETATE	CAPSULE;ORAL	CAPSULE	ORAL	CALCIUM ACETATE	HERITAGE PHARMS INC	667MG	AB	["AB"]	2015-06-29	Jun 29, 2015	No	No	No	RX	HERITAGE PHARMACEUTICALS INC	`5181d2064745d237822f03f09ecc3ad06e3e6bc0c53b1d7345d2ac3cef72ecf6`
1923	A	077728	001	CALCIUM ACETATE	CAPSULE;ORAL	CAPSULE	ORAL	CALCIUM ACETATE	HIKMA	667MG	AB	["AB"]	2008-02-26	Feb 26, 2008	No	No	No	RX	HIKMA PHARMACEUTICALS USA INC	`7964cc043ce86573222b27764af9dac2804ffbf2108d371fca7efb687a5a4109`
1924	A	203135	001	CALCIUM ACETATE	CAPSULE;ORAL	CAPSULE	ORAL	CALCIUM ACETATE	INVAGEN PHARMS	667MG	AB	["AB"]	2013-02-07	Feb 7, 2013	No	No	No	RX	INVAGEN PHARMACEUTICALS INC	`e3d6b8bc3ef88adb7894fb41e5076cedb7ff7f8d36b347e355c036e96fe29c79`
1925	A	203298	001	CALCIUM ACETATE	CAPSULE;ORAL	CAPSULE	ORAL	CALCIUM ACETATE	LOTUS PHARM CO LTD	667MG		[]	2016-07-26	Jul 26, 2016	No	No	No	DISCN	LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT	`3f07abd8a73e5308015f391e60bcf1f7f59dc78d1ff57249b5ae7cab3eff2fef`
1926	A	202127	001	CALCIUM ACETATE	CAPSULE;ORAL	CAPSULE	ORAL	CALCIUM ACETATE	LUPIN LTD	667MG	AB	["AB"]	2015-07-09	Jul 9, 2015	No	No	No	RX	LUPIN LTD	`b6611f2d0ead88e4e8c362f9dc6930f8dd870d4608e56faa569b6042bae15511`
1927	A	203179	001	CALCIUM ACETATE	CAPSULE;ORAL	CAPSULE	ORAL	CALCIUM ACETATE	NOSTRUM LABS INC	667MG	AB	["AB"]	2015-10-26	Oct 26, 2015	No	No	No	RX	NOSTRUM LABORATORIES INC	`49f9379518b9b428ee4b093e0d2d7a68315f9801c2f48efab12801cfc692fbbf`
1928	A	211038	001	CALCIUM ACETATE	CAPSULE;ORAL	CAPSULE	ORAL	CALCIUM ACETATE	SUVEN PHARMS	667MG	AB	["AB"]	2020-02-21	Feb 21, 2020	No	No	No	RX	SUVEN PHARMACEUTICALS LTD	`1cc6386e3c3bbc3b6911e837ef4e06e5d8718819d78720d51ed114af78695caa`
1929	N	018312	001	CALCIFEDIOL	CAPSULE;ORAL	CAPSULE	ORAL	CALDEROL	ORGANON USA INC	0.02MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	ORGANON USA INC	`7a9326d67476e79aaf5c9893f4d3b477f30beaec3e94cecca216f8b8e62f64b1`
1930	N	018312	002	CALCIFEDIOL	CAPSULE;ORAL	CAPSULE	ORAL	CALDEROL	ORGANON USA INC	0.05MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	ORGANON USA INC	`d9ae869909396091dd328c19eebb68644d4961bdda5c1dc78973765cfbcfa21e`
1931	N	210259	001	ACALABRUTINIB	CAPSULE;ORAL	CAPSULE	ORAL	CALQUENCE	ASTRAZENECA	100MG		[]	2017-10-31	Oct 31, 2017	No	Yes	Yes	RX	ASTRAZENECA UK LTD	`e92fbfa7d330c276ab7f2180cabb05cf53fe7d565cbed532a9b827a5f7e46920`
1932	N	209500	001	LUMATEPERONE TOSYLATE	CAPSULE;ORAL	CAPSULE	ORAL	CAPLYTA	INTRA-CELLULAR	EQ 42MG BASE		[]	2019-12-20	Dec 20, 2019	No	Yes	Yes	RX	INTRA-CELLULAR THERAPIES INC	`81a78eae648cd3848d22b579fc6b371ab449e978dcbeb223fb3ab712d4127b46`
1933	N	019488	001	NICARDIPINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	CARDENE	CHIESI	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1988-12-21	Dec 21, 1988	No	No	No	DISCN	CHIESI USA INC	`53ca02e7be30ecdf584a651ed0090c2bdfd3b628d7de756d55b9bc8d9e3f7de0`
1934	N	019488	002	NICARDIPINE HYDROCHLORIDE	CAPSULE;ORAL	CAPSULE	ORAL	CARDENE	CHIESI	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons		[]	1988-12-21	Dec 21, 1988	No	No	No	DISCN	CHIESI USA INC	`35d1db5becc371196f7d32d8f5bee0d95b8c154986cbd613ff3ae5f8575c1cea`
1935	N	050521	001	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CECLOR	LILLY	EQ 250MG BASE 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	ELI LILLY AND CO	`6804a5066e5d6cfba8e05007ffe93d65c9a835ff754a94c6cc4047218868d0df`
1936	N	050521	002	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CECLOR	LILLY	EQ 500MG BASE 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	ELI LILLY AND CO	`0695c63b5dbe907b2c8d800ea7e073dbdba3df72007a91039f42b2fa8af0c082`
1937	N	050685	002	CEFTIBUTEN DIHYDRATE	CAPSULE;ORAL	CAPSULE	ORAL	CEDAX	SI PHARMS	EQ 400MG BASE		[]	1995-12-20	Dec 20, 1995	No	No	No	DISCN	SI PHARMACEUTICALS LLC	`8eba7620086e1f787eed82562172ecb93e5d93b77c63ed751e77c98ff6f3ea28`
1938	A	062205	001	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CEFACLOR	CEPH INTL	EQ 250MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	CEPH INTERNATIONAL CORP	`b35306e268a0670839530629b07b34648365b9cd4890344122d8144f52eef98c`
1939	A	062205	002	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CEFACLOR	CEPH INTL	EQ 500MG BASE		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	CEPH INTERNATIONAL CORP	`1a537b25c3e31d96e63612fb163cf66fb228986448d34e7e17124978dd103856`
1940	A	064107	001	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CEFACLOR	DAVA PHARMS INC	EQ 250MG BASE		[]	1995-04-27	Apr 27, 1995	No	No	No	DISCN	DAVA PHARMACEUTICALS INC	`011f2f8cf6abb05a4296e515153f61ad81a442f83f28fc5ac26b0c0df45b4731`
1941	A	064107	002	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CEFACLOR	DAVA PHARMS INC	EQ 500MG BASE		[]	1995-04-27	Apr 27, 1995	No	No	No	DISCN	DAVA PHARMACEUTICALS INC	`6b746c34bee94e840437fe56a6d6e0255d0469a39f60bf9468e459fb2465ec9b`
1942	A	064148	001	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CEFACLOR	HERITAGE PHARMA	EQ 250MG BASE		[]	1996-05-23	May 23, 1996	No	No	No	DISCN	HERITAGE PHARMA LABS INC	`da49f28f0bde1722c85225d4973265e1b898e02231dd3da783adf04f7f7bcf1d`
1943	A	064148	002	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CEFACLOR	HERITAGE PHARMA	EQ 500MG BASE		[]	1996-05-23	May 23, 1996	No	No	No	DISCN	HERITAGE PHARMA LABS INC	`ae6240fb08f35b10ecff8eafd7027610dd44e19282aa6a23a6dff861f18d4758`
1944	A	065350	001	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CEFACLOR	HIKMA	EQ 250MG BASE	AB	["AB"]	2007-04-03	Apr 3, 2007	No	No	No	RX	HIKMA PHARMACEUTICALS	`e75246ca066ddf8a7f644f510451c8ad5b0ec4f1d45017f0799fd5864e332520`
1945	A	065350	002	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CEFACLOR	HIKMA	EQ 500MG BASE	AB	["AB"]	2007-04-03	Apr 3, 2007	No	No	Yes	RX	HIKMA PHARMACEUTICALS	`7d25a5e478e0e799d4d9178aceb59f04871339d879c9d183c33b98e1fb6cd0ec`
1946	A	064061	001	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CEFACLOR	IVAX SUB TEVA PHARMS	EQ 250MG BASE		[]	1995-04-27	Apr 27, 1995	No	No	No	DISCN	IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA	`1afd1abc8fa5e26d0f9236f9b913fc9fc063488a8d649c4c83bd33f883090e3e`
1947	A	064061	002	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CEFACLOR	IVAX SUB TEVA PHARMS	EQ 500MG BASE		[]	1995-04-27	Apr 27, 1995	No	No	No	DISCN	IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA	`aa13169d0508b8ccb4f419fb9f5972e8badbdccbda772e55a19d01f85e1344d2`
1948	A	064156	001	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CEFACLOR	RANBAXY	EQ 250MG BASE		[]	1997-08-28	Aug 28, 1997	No	No	No	DISCN	RANBAXY PHARMACEUTICALS INC	`5036a261f6e0b50a3f6f3b506cf787a3b0753af341d3ed46a615b7c735adbbe0`
1949	A	064156	002	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CEFACLOR	RANBAXY	EQ 500MG BASE		[]	1997-08-28	Aug 28, 1997	No	No	No	DISCN	RANBAXY PHARMACEUTICALS INC	`9bdbad139698a4a6ee48e5d7db5d00a3e8f693c390d368d48a75d345506b45c6`
1950	A	064081	001	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CEFACLOR	TEVA	EQ 250MG BASE		[]	1996-09-16	Sep 16, 1996	No	No	No	DISCN	TEVA PHARMACEUTICALS USA INC	`1e3d57c1eafaa224f2a072870eb65a19d6964dd17137596d9066af831c3ff1de`
1951	A	064145	001	CEFACLOR	CAPSULE;ORAL	CAPSULE	ORAL	CEFACLOR	TEVA	EQ 250MG BASE		[]	1996-06-24	Jun 24, 1996	No	No	No	DISCN	TEVA PHARMACEUTICALS USA INC	`2a0269f5658e093aeb09b06e5e96760ce9ad96247d447d8f98004a9e775ba7e5`