Orange Book snapshot 41: Products

Products page 1 of 956 · 47,780 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	A	215328	001	BUDESONIDE	AEROSOL, FOAM;RECTAL	AEROSOL, FOAM	RECTAL	BUDESONIDE	PADAGIS ISRAEL	2MG/ACTUATION	AB	["AB"]	2023-04-12	Apr 12, 2023	No	No	Yes	RX	PADAGIS ISRAEL PHARMACEUTICALS LTD	`f3a4430c87471f63b6428f9a04b2041da1f11e3f1e05bbbe5b4560bdac51397d`
3	N	205613	001	BUDESONIDE	AEROSOL, FOAM;RECTAL	AEROSOL, FOAM	RECTAL	UCERIS	SALIX	2MG/ACTUATION	AB	["AB"]	2014-10-07	Oct 7, 2014	No	Yes	No	RX	SALIX PHARMACEUTICALS INC	`ae61428ed274f2bbd4033afbd79d8f63365d254bf4987321ce3e47febf3162c4`
4	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`
5	A	210928	001	AZELAIC ACID	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	AZELAIC ACID	AUROBINDO PHARMA USA	15%		[]	2020-10-07	Oct 7, 2020	No	No	No	DISCN	AUROBINDO PHARMA USA INC	`7957d206259f755198d7b1d7479de491fb9051dfec4e24c5a2461c86fd35c138`
6	A	215832	001	BETAMETHASONE VALERATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	BETAMETHASONE VALERATE	ALEMBIC	0.12%	AB	["AB"]	2024-08-22	Aug 22, 2024	No	No	No	RX	ALEMBIC PHARMACEUTICALS LTD	`785224d50b69cf4305ce04195ae6c2d5279baa5d00ef0b87914644429aa85deb`
7	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`
8	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`
9	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	Yes	RX	TARO PHARMACEUTICAL INDUSTRIES LTD	`ea53705526b4537c9340ca88cd7d48dd882d5f425654469a382a0759912831a2`
10	A	210639	001	BETAMETHASONE VALERATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	BETAMETHASONE VALERATE	XIROMED	0.12%	AB	["AB"]	2023-04-18	Apr 18, 2023	No	No	No	RX	XIROMED PHARMA ESPANA SL	`58997035dde1cb484c7fa985e7f36cd9d0e05b87a2796662d032de89a886102f`
11	A	214688	001	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	GLENMARK PHARMS LTD	0.064%;0.005%		[]	2023-03-21	Mar 21, 2023	No	No	No	DISCN	GLENMARK PHARMACEUTICALS LTD	`dd4c0f7414d9d41ccde8c0559058a623ce2e739fccdaecb60f1f12f9d7a5a4bf`
12	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`
13	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	Yes	RX	PADAGIS ISRAEL PHARMACEUTICALS LTD	`3284d71caa223a76ee109bc998134d2c0a008685d91a014ac47c0c4026ecde59`
14	A	210004	001	CLINDAMYCIN PHOSPHATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CLINDAMYCIN PHOSPHATE	TARO	1%	AT	["AT"]	2020-03-11	Mar 11, 2020	No	No	No	RX	TARO PHARMACEUTICAL INDUSTRIES LTD	`9d78fcdc40b7b75ad1def5062f9ecee394e362fbfcd28686170dc728a993bc10`
15	A	215838	001	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CLOBETASOL PROPIONATE	ALEMBIC	0.05%	AB1	["AB1"]	2022-04-21	Apr 21, 2022	No	No	No	RX	ALEMBIC PHARMACEUTICALS LTD	`53488995a1474afdbdcd73e81f55908f71807582f9710e32c7a817ad3e79d5a2`
16	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`
17	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`
18	A	206805	001	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CLOBETASOL PROPIONATE	NOVAST LABS	0.05%		[]	2017-07-31	Jul 31, 2017	No	No	No	DISCN	NOVAST LABORATORIES LTD	`ca80f6e4429e6c8ec908d18aa5a5d87c92f0d1a08344db2193118d369b37e12d`
19	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`
20	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	Yes	RX	PADAGIS ISRAEL PHARMACEUTICALS LTD	`47a06c35c78bf174b2a7397815d1bb58c11a2ab09d06971be46b6659f21a8011`
21	A	208563	001	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CLOBETASOL PROPIONATE	TARO	0.05%		[]	2024-03-14	Mar 14, 2024	No	No	No	DISCN	TARO PHARMACEUTICAL INDUSTRIES LTD	`164408c07322b9aa71508686790b8ec05cc36f3a2c26004703c811a399ca9e9e`
22	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	Yes	RX	TARO PHARMACEUTICAL INDUSTRIES LTD	`eb3d86e44d3e24524e5edef7da8beee0407620c986fea39070fec27a03f429f3`
23	A	210638	001	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	CLOBETASOL PROPIONATE	XIROMED	0.05%	AB1	["AB1"]	2025-11-20	Nov 20, 2025	No	No	No	RX	XIROMED PHARMA ESPANA SL	`efc7d50d1a07c0b0953a1e713fe8a21ec12eae02598e9c8860ba87e352e298cd`
24	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`
25	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`
26	N	050801	001	CLINDAMYCIN PHOSPHATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	EVOCLIN	NORVIUM BIOSCIENCE	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons		[]	2004-10-22	Oct 22, 2004	No	Yes	No	DISCN	NORVIUM BIOSCIENCE LLC	`5ee298c1fe5ecbbed16d73d0015fcbeb6303304692cdfbb9df511e751a15d081`
27	N	021738	001	KETOCONAZOLE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	EXTINA	RISING	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons		[]	2007-06-12	Jun 12, 2007	No	Yes	No	DISCN	RISING PHARMA HOLDINGS INC	`b70bfd4afce08992d4d7049e4e5a29d8363f2ead354804ead7bc0cc014c42f10`
28	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`
29	N	207071	001	AZELAIC ACID	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	FINACEA	LEO PHARMA AS	15%		[]	2015-07-29	Jul 29, 2015	No	Yes	Yes	RX	LEO PHARMA AS	`c5b149ef4c20f3306dd399c7b4e17f7ff261e4b685fad189afbbe6094bf737d1`
30	A	215266	001	HALOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	HALOBETASOL PROPIONATE	PADAGIS ISRAEL	0.05%	AB	["AB"]	2023-08-11	Aug 11, 2023	No	No	No	RX	PADAGIS ISRAEL PHARMACEUTICALS LTD	`41de6ae783842ff9f1a9be8e21247212be716ba2cd99f62f9fcb3a30a2cff28d`
31	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`
32	A	213601	001	KETOCONAZOLE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	KETOCONAZOLE	XIROMED	2%	AB	["AB"]	2021-05-21	May 21, 2021	No	No	Yes	RX	XIROMED PHARMA ESPANA SL	`cc024c28013c6c645358f4e56d2a7ccc16b3e8b72b7caf41c1f172b4f18bf161`
33	N	210566	001	HALOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	LEXETTE	MAYNE PHARMA	0.05%	AB	["AB"]	2018-05-24	May 24, 2018	No	Yes	Yes	RX	MAYNE PHARMA LLC	`b8fe134d20be1ce016a6012aeffa7a009735b1337eff5a1d0a19484f66729080`
34	N	020934	001	BETAMETHASONE VALERATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	LUXIQ	PHARMOBEDIENT	0.12% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons		[]	1999-02-28	Feb 28, 1999	No	Yes	No	DISCN	PHARMOBEDIENT CONSULTING LLC	`ec01fa17f0383c86900179c25edbe65b3c791ce257b43fcc919a706f5c467f00`
35	N	021812	001	MINOXIDIL	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	MEN'S ROGAINE	KENVUE BRANDS	5%		[]	2006-01-20	Jan 20, 2006	No	Yes	Yes	OTC	KENVUE BRANDS LLC	`8c452e4f73270b96458579a60839a3434a334513fc472358198e1b28aea85e98`
36	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`
37	A	218616	001	MINOXIDIL	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	MINOXIDIL (FOR MEN)	AUROBINDO PHARMA	5%		[]	2024-04-22	Apr 22, 2024	No	No	No	OTC	AUROBINDO PHARMA LTD	`a88902687959618270dc99b82617393a6bd404880222bcbe3a5ea42ed334d237`
38	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`
39	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`
40	A	218616	002	MINOXIDIL	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	MINOXIDIL (FOR WOMEN)	AUROBINDO PHARMA	5%		[]	2024-04-22	Apr 22, 2024	No	No	No	OTC	AUROBINDO PHARMA LTD	`7d5483d2975a8b29efb7f1792e1484473942f3f998fe0e007d0304f6606af466`
41	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`
42	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`
43	N	021142	001	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	OLUX	PHARMOBEDIENT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons		[]	2000-05-26	May 26, 2000	No	Yes	No	DISCN	PHARMOBEDIENT CONSULTING LLC	`42735356fb818b444a3f03c0fb591844a24375f0a54afb8db2810a8c51ddfeb0`
44	N	022013	001	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	OLUX E	PHARMOBEDIENT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons		[]	2007-01-12	Jan 12, 2007	No	Yes	No	DISCN	PHARMOBEDIENT CONSULTING LLC	`f2ae7ba72faeba1af642e238089d98880d5e11b6c0869e09edc28668dfe698c6`
45	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`
46	N	021978	001	DESONIDE	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	VERDESO	ALMIRALL	0.05%		[]	2006-09-19	Sep 19, 2006	No	Yes	No	DISCN	ALMIRALL LLC	`68cf3fb91819387aa40e0a74ca5d86da4ba1aba896c402b6f9d9d9690883db2b`
47	N	021812	002	MINOXIDIL	AEROSOL, FOAM;TOPICAL	AEROSOL, FOAM	TOPICAL	WOMEN'S ROGAINE	KENVUE BRANDS	5%		[]	2014-02-28	Feb 28, 2014	No	Yes	Yes	OTC	KENVUE BRANDS LLC	`215b66abdd8f8f0cf51bf0f6fdbdadacc6384cdf73e36729c8e7da4ef5655d3b`
48	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`
49	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`
50	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`
51	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`