Orange Book snapshot 4: Products

Products page 1 of 844 · 42,191 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
2	N	205613	001	BUDESONIDE	AEROSOL, FOAM;RECTAL	AEROSOL, FOAM	RECTAL	UCERIS	SALIX	2MG/ACTUATION		[]	2014-10-07	Oct 7, 2014	No	Yes	Yes	RX	SALIX PHARMACEUTICALS INC	`cab0caabc9b2280c212f9439c6023f75d01561385f2195fa77d0bb48854e42bf`
3	N	212379	001	MINOCYCLINE HYDROCHLORIDE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	AMZEEQ	JOURNEY	EQ 4% BASE		[]	2019-10-18	Oct 18, 2019	No	Yes	Yes	RX	JOURNEY MEDICAL CORP	`c2d8765c93f697ab94a6b1ee36a52fa12c4f97c5869f48922687c0f2380c653a`
4	A	210928	001	AZELAIC ACID	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	AZELAIC ACID	TEVA PHARMS USA	15%		[]	2020-10-07	Oct 7, 2020	No	No	No	DISCN	TEVA PHARMACEUTICALS USA INC	`c95613ff55aef6a83d024437d3c923f6b7358c20a26bdfcb131dc9cd17024211`
5	A	207144	001	BETAMETHASONE VALERATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	BETAMETHASONE VALERATE	NOVAST LABS	0.12%		[]	2017-05-24	May 24, 2017	No	No	No	DISCN	NOVAST LABORATORIES LTD	`879dedbaf966cfcf668fba9e3cc30a6e2524d086b6c5553e678461f2ca6cab0c`
6	A	078337	001	BETAMETHASONE VALERATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	BETAMETHASONE VALERATE	PADAGIS ISRAEL	0.12%	AB	["AB"]	2012-11-26	Nov 26, 2012	No	No	No	RX	PADAGIS ISRAEL PHARMACEUTICALS LTD	`99254e6b3052126a19962dee01058a8586a2c71e971a65713b91162fe8e8dcbe`
7	A	208204	001	BETAMETHASONE VALERATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	BETAMETHASONE VALERATE	TARO	0.12%	AB	["AB"]	2017-05-24	May 24, 2017	No	No	No	RX	TARO PHARMACEUTICAL INDUSTRIES LTD	`188dd26973c81c05b5456cab06177418950de01ce59d0e935b536fd235b4bc11`
8	A	210778	001	CLINDAMYCIN PHOSPHATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CLINDAMYCIN PHOSPHATE	GLENMARK PHARMS LTD	1%	AT	["AT"]	2021-09-20	Sep 20, 2021	No	No	No	RX	GLENMARK PHARMACEUTICALS LTD	`36bbfcc496eb8a4d06f61de1d8f0f709d2077ded246410b884548f236ebdd9f0`
9	A	090785	001	CLINDAMYCIN PHOSPHATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CLINDAMYCIN PHOSPHATE	PADAGIS ISRAEL	1%	AT	["AT"]	2010-03-31	Mar 31, 2010	No	No	No	RX	PADAGIS ISRAEL PHARMACEUTICALS LTD	`7c38981d8ee46f85fca7cd3afc167300ffbad5d3187f7f7655e013a92a3584a2`
10	A	210004	001	CLINDAMYCIN PHOSPHATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CLINDAMYCIN PHOSPHATE	TARO PHARM INDS LTD	1%		[]	2020-03-11	Mar 11, 2020	No	No	No	DISCN	TARO PHARMACEUTICAL INDUSTRIES LTD	`a8e5d29b20193fa0038335a427e83cb796eb3c7d68e32d5cfa266fc48d13b903`
11	A	215838	001	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CLOBETASOL PROPIONATE	ALEOR DERMACEUTICALS	0.05%	AB1	["AB1"]	2022-04-21	Apr 21, 2022	No	No	No	RX	ALEOR DERMACEUTICALS LTD	`fc55468d7687af47d34bf2309f34479901594736ea718b1d0b170c4026361498`
12	A	210809	001	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CLOBETASOL PROPIONATE	GLENMARK PHARMS LTD	0.05%	AB1	["AB1"]	2019-02-15	Feb 15, 2019	No	No	No	RX	GLENMARK PHARMACEUTICALS LTD	`90c9a2311aaeea29fcc8e773100051b43d9cacf43025e115127bf88cc506b08c`
13	A	211450	001	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CLOBETASOL PROPIONATE	GLENMARK PHARMS LTD	0.05%	AB2	["AB2"]	2019-09-09	Sep 9, 2019	No	No	No	RX	GLENMARK PHARMACEUTICALS LTD	`e6b1af0803afa1f36b53b5feed328429c7107547d6f68bf570ab1fde87e5002d`
14	A	206805	001	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CLOBETASOL PROPIONATE	INGENUS PHARMS LLC	0.05%		[]	2017-07-31	Jul 31, 2017	No	No	No	DISCN	INGENUS PHARMACEUTICALS LLC	`68d927f7e42efffccd5c79c3045b2ea2e4f7f484f5eab323e45ce1ada8acad56`
15	A	077763	001	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CLOBETASOL PROPIONATE	PADAGIS ISRAEL	0.05%	AB1	["AB1"]	2008-03-10	Mar 10, 2008	No	No	No	RX	PADAGIS ISRAEL PHARMACEUTICALS LTD	`ac756d1e7e024a1a09ad40d4981afdb4227b385cf673580a0528e3605c8d0c88`
16	A	201402	001	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CLOBETASOL PROPIONATE	PADAGIS ISRAEL	0.05%	AB2	["AB2"]	2012-08-14	Aug 14, 2012	No	No	No	RX	PADAGIS ISRAEL PHARMACEUTICALS LTD	`3beb1f4ff5ec8816a1bd72c0b38895327c4e2dbda31bb7c77d5209f693f6309a`
17	A	208779	001	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CLOBETASOL PROPIONATE	TARO	0.05%	AB1	["AB1"]	2018-10-04	Oct 4, 2018	No	No	No	RX	TARO PHARMACEUTICAL INDUSTRIES LTD	`696a8da3d28612739721a878821c0f729161f5cb1bd32c7e48b9f47af8fad6cb`
18	N	205175	001	ECONAZOLE NITRATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	ECOZA	RESILIA PHARMS	1%		[]	2013-10-24	Oct 24, 2013	No	Yes	Yes	RX	RESILIA PHARMACEUTICALS INC	`c2ca4ae0852a49df07354bfaf4df9a62e55ce5ce9da656483c59256dcb63246b`
19	N	207589	001	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	ENSTILAR	LEO PHARMA AS	0.064%;0.005%		[]	2015-10-16	Oct 16, 2015	No	Yes	Yes	RX	LEO PHARMA AS	`93200f740f49284bf1500d50f311b2da4693999c7ec9f58fc1d2bfcca0632004`
20	N	050801	001	CLINDAMYCIN PHOSPHATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	EVOCLIN	MYLAN	1%	AT	["AT"]	2004-10-22	Oct 22, 2004	No	Yes	Yes	RX	MYLAN PHARMACEUTICALS INC	`c173385412061526b7a1e9954ac41584759f51a6e87807b9c198949aa4cccc63`
21	N	021738	001	KETOCONAZOLE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	EXTINA	MYLAN	2%	AB	["AB"]	2007-06-12	Jun 12, 2007	No	Yes	Yes	RX	MYLAN PHARMACEUTICALS INC	`a5ff64074121d6c531f773447466f8186a891c17b3201b30d156df868c3cf665`
22	N	202428	001	TAZAROTENE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	FABIOR	MAYNE PHARMA	0.1%		[]	2012-05-11	May 11, 2012	No	Yes	Yes	RX	MAYNE PHARMA LLC	`72c78eee5a9dd0ce197129a158a10847a777cba5e0f4347cbb7219408d672c8a`
23	N	207071	001	AZELAIC ACID	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	FINACEA	LEO PHARMA AS	15%	AB	["AB"]	2015-07-29	Jul 29, 2015	No	Yes	Yes	RX	LEO PHARMA AS	`484fbd795ed8391b4acb79e90bcd3a25faedd0d11789b56efaee80382e77872f`
24	A	091550	001	KETOCONAZOLE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	KETOCONAZOLE	PADAGIS ISRAEL	2%	AB	["AB"]	2011-08-25	Aug 25, 2011	No	No	No	RX	PADAGIS ISRAEL PHARMACEUTICALS LTD	`8d201a8ac3a646f3bc6eb3ac44594d56e0219a244b44119e354d41f777746e02`
25	A	213601	001	KETOCONAZOLE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	KETOCONAZOLE	XIROMED	2%	AB	["AB"]	2021-05-21	May 21, 2021	No	No	No	RX	XIROMED PHARMA ESPANA SL	`ee6c2865bbececa10341fe0808e65b78032d6fd966872fc35e34d1949f96658e`
26	N	210566	001	HALOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	LEXETTE	MAYNE PHARMA	0.05%		[]	2018-05-24	May 24, 2018	No	Yes	Yes	RX	MAYNE PHARMA LLC	`10feb5d4034e94ac5de6ae6d4a90d3a3aa416c9eb67ea3826f29b41a3953ea64`
27	N	020934	001	BETAMETHASONE VALERATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	LUXIQ	MYLAN	0.12%	AB	["AB"]	1999-02-28	Feb 28, 1999	No	Yes	Yes	RX	MYLAN PHARMACEUTICALS INC	`74c1c953de57a681166ba2e885fc2c8165d109bdce61842ceb83d9725881d182`
28	N	021812	001	MINOXIDIL	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	MEN'S ROGAINE	JOHNSON AND JOHNSON	5%		[]	2006-01-20	Jan 20, 2006	No	Yes	Yes	OTC	JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES	`da5e2a8e40a5ac72392b88779e18015623158fd950de124f59c66f7eff589f69`
29	A	091344	001	MINOXIDIL	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	MINOXIDIL	PERRIGO PHARMA INTL	5%		[]	2011-04-28	Apr 28, 2011	No	No	No	OTC	PERRIGO PHARMA INTERNATIONAL DAC	`c926f12f8112ae85cdec32d8257c3d191cd8c6b59974fae83ace44b558df6bd7`
30	A	208092	001	MINOXIDIL	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	MINOXIDIL (FOR MEN)	P AND L	5%		[]	2017-02-17	Feb 17, 2017	No	No	No	OTC	P AND L DEVELOPMENT LLC	`fba35591d677b959847fbb588e9825dba42d9620d79bc0c538013cf4189183f4`
31	A	209074	001	MINOXIDIL	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	MINOXIDIL (FOR MEN)	TARO	5%		[]	2018-12-31	Dec 31, 2018	No	No	No	OTC	TARO PHARMACEUTICAL INDUSTRIES LTD	`f8b884720272b6185418316affabca062a15c0dbcbf5bfbc25c022dfad63455d`
32	A	208092	002	MINOXIDIL	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	MINOXIDIL (FOR WOMEN)	P AND L	5%		[]	2017-07-27	Jul 27, 2017	No	No	No	OTC	P AND L DEVELOPMENT LLC	`e311aad88f4445c502a1dfaecb3c36c0d44d5ae702e34ef559a4d90dfa9be139`
33	A	209074	002	MINOXIDIL	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	MINOXIDIL (FOR WOMEN)	TARO	5%		[]	2019-04-22	Apr 22, 2019	No	No	No	OTC	TARO PHARMACEUTICAL INDUSTRIES LTD	`3f72c55683d6aeae4eb8998cdeb9b5ad482d44b8298ca012e53cc9ab0bb28a50`
34	N	021142	001	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	OLUX	MYLAN	0.05%	AB1	["AB1"]	2000-05-26	May 26, 2000	No	Yes	Yes	RX	MYLAN PHARMACEUTICALS INC	`521133c7905ce203636011ece7fccadbb1295690c3d3d93b0e860c8dee55c53f`
35	N	022013	001	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	OLUX E	MYLAN	0.05%	AB2	["AB2"]	2007-01-12	Jan 12, 2007	No	Yes	Yes	RX	MYLAN PHARMACEUTICALS INC	`34ac2242be437943d8b6f3a3d9064679b8e59cd7491fa33a3882503b7e39fb9e`
36	N	022563	001	CALCIPOTRIENE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	SORILUX	MAYNE PHARMA	0.005%		[]	2010-10-06	Oct 6, 2010	No	Yes	Yes	RX	MAYNE PHARMA LLC	`b845f551ab306c625ba76f23fb727bbfa2cac500f1eb7d9469e63f7e3d79fafe`
37	N	021978	001	DESONIDE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	VERDESO	ALMIRALL	0.05%		[]	2006-09-19	Sep 19, 2006	No	Yes	Yes	RX	ALMIRALL LLC	`8c23a0bbb09237ae32ea70658d1383149c769c3ad12349b02b253beedc3024fb`
38	N	021812	002	MINOXIDIL	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	WOMEN'S ROGAINE	JOHNSON AND JOHNSON	5%		[]	2014-02-28	Feb 28, 2014	No	Yes	Yes	OTC	JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES	`a740366810b5d463bff3841e3da96d766b0ada31610da334b4628166d09f2112`
39	N	213690	001	MINOCYCLINE HYDROCHLORIDE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	ZILXI	JOURNEY	EQ 1.5% BASE		[]	2020-05-28	May 28, 2020	No	Yes	Yes	RX	JOURNEY MEDICAL CORP	`813ae2c7f1be789aa6c1ea812222dc6cabf9000972ab2d8643c0fa2114db752f`
40	N	021254	001	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	AEROSOL, METERED;INHALATION	AEROSOL, METERED	INHALATION	ADVAIR HFA	GLAXO GRP LTD	0.045MG/INH;EQ 0.021MG BASE/INH		[]	2006-06-08	Jun 8, 2006	No	Yes	Yes	RX	GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE	`1c4810307ba521b73ee98d3cb9dae844066cceac8110e16878182b40711612dd`
41	N	021254	002	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	AEROSOL, METERED;INHALATION	AEROSOL, METERED	INHALATION	ADVAIR HFA	GLAXO GRP LTD	0.115MG/INH;EQ 0.021MG BASE/INH		[]	2006-06-08	Jun 8, 2006	No	Yes	Yes	RX	GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE	`9ace23c8cec8cc31ddad61cb6ae4572c111228b8a0020fe6afae19b39c80d234`
42	N	021254	003	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	AEROSOL, METERED;INHALATION	AEROSOL, METERED	INHALATION	ADVAIR HFA	GLAXO GRP LTD	0.23MG/INH;EQ 0.021MG BASE/INH		[]	2006-06-08	Jun 8, 2006	No	Yes	Yes	RX	GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE	`49196ed0d7130035af4d9572562375f1ea68e961e95df77856374449cdff2be6`
43	N	018340	001	FLUNISOLIDE	AEROSOL, METERED;INHALATION	AEROSOL, METERED	INHALATION	AEROBID	ROCHE PALO	0.25MG/INH		[]	1984-08-17	Aug 17, 1984	No	No	No	DISCN	ROCHE PALO ALTO LLC	`544314598a82698a6d4d4afabf3a6696ecf2960e1e93275616e48ab271ed419c`
44	N	021247	001	FLUNISOLIDE	AEROSOL, METERED;INHALATION	AEROSOL, METERED	INHALATION	AEROSPAN HFA	MYLAN SPECIALITY LP	0.078MG/INH		[]	2006-01-27	Jan 27, 2006	No	Yes	No	DISCN	MYLAN SPECIALTY LP	`8df51b92694dec3d3504256b1e2e0ca77197371e2ccc3d240a1302a6fc4dd0c3`
45	A	072273	001	ALBUTEROL	AEROSOL, METERED;INHALATION	AEROSOL, METERED	INHALATION	ALBUTEROL	ARMSTRONG PHARMS	0.09MG/INH		[]	1996-08-14	Aug 14, 1996	No	No	No	DISCN	ARMSTRONG PHARMACEUTICALS INC	`fda713ac4a95795bf47e948764531baa5f6a81cf730ea75ca502e5391ee68880`
46	A	073045	001	ALBUTEROL	AEROSOL, METERED;INHALATION	AEROSOL, METERED	INHALATION	ALBUTEROL	GENPHARM	0.09MG/INH		[]	1997-08-19	Aug 19, 1997	No	No	No	DISCN	GENPHARM INC	`7f1f36cfe9a418a7636a3457cee6332e470e739dfa68c1b52c5f3940be071fc3`
47	A	073272	001	ALBUTEROL	AEROSOL, METERED;INHALATION	AEROSOL, METERED	INHALATION	ALBUTEROL	IVAX SUB TEVA PHARMS	0.09MG/INH		[]	1995-12-28	Dec 28, 1995	No	No	No	DISCN	IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA	`a9fb7176e033f80ebd5cf14d9ceb57117e4677466bd91e6ebafe63ed392829b6`
48	A	074072	001	ALBUTEROL	AEROSOL, METERED;INHALATION	AEROSOL, METERED	INHALATION	ALBUTEROL	PLIVA	0.09MG/INH		[]	1996-08-01	Aug 1, 1996	No	No	No	DISCN	PLIVA INC	`65ce7c3e3a3c9d5eec93dc24efabcda227d1dd675869a19a2e16efd7f8e34d77`
49	A	209959	001	ALBUTEROL SULFATE	AEROSOL, METERED;INHALATION	AEROSOL, METERED	INHALATION	ALBUTEROL SULFATE	CIPLA	EQ 0.09MG BASE/INH	AB1	["AB1"]	2020-04-08	Apr 8, 2020	No	No	No	RX	CIPLA LTD	`e562603a1e6abbdd3e596b8ec68a8bb9072cff987398edc6bf87ae7a2a895cd2`
50	A	209954	001	ALBUTEROL SULFATE	AEROSOL, METERED;INHALATION	AEROSOL, METERED	INHALATION	ALBUTEROL SULFATE	LUPIN	EQ 0.09MG BASE/INH	AB2	["AB2"]	2020-08-24	Aug 24, 2020	No	No	No	RX	LUPIN INC	`fb34c53a46bfd33ee46e1d8c017838e89705e52931e91f2ab3ab70f5080ebf08`
51	A	203760	001	ALBUTEROL SULFATE	AEROSOL, METERED;INHALATION	AEROSOL, METERED	INHALATION	ALBUTEROL SULFATE	PADAGIS US	EQ 0.09MG BASE/INH		[]	2020-02-24	Feb 24, 2020	No	No	No	DISCN	PADAGIS US LLC	`94e0007984bd29f9813ac679714e28c1a3e131a6b51509387c9d4705f2e59caf`