← Snapshot 21

Orange Book snapshot 21: Products

Products page 3 of 799 · 39,901 matching rows.

Source row, Application type, Application number table
Source rowApplication typeApplication numberProduct numberIngredient rawDosage form / route rawDosage formRouteTrade nameApplicantStrength rawTE rawTE JSONApproval dateApproval date rawApproved before 1982RLDRSProduct typeApplicant full nameRaw row SHA-256
102N021929002BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONSYMBICORTASTRAZENECA0.16MG/INH;0.0045MG/INH[]2006-07-21Jul 21, 2006NoYesYesRXASTRAZENECA LPcd149949f13c3da091fde219ab75232c8f03f1667b15141f93d1f535864b02f2
103N019660001NEDOCROMIL SODIUMAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONTILADEKING PHARMS LLC1.75MG/INH[]1992-12-30Dec 30, 1992NoNoNoDISCNKING PHARMACEUTICALS LLCb037f96e90ef59d8fc702bbd841d4b173b8821db12e9feeb7c93d75b58e75bcc
104N018770001BITOLTEROL MESYLATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONTORNALATESANOFI AVENTIS US0.37MG/INH[]1984-12-28Dec 28, 1984NoNoNoDISCNSANOFI AVENTIS US LLC5d96de90c97ae9d1598416bce8c1e2c8fe968fcf0309d205174eb32005d1761d
105N017573001BECLOMETHASONE DIPROPIONATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONVANCERILSCHERING0.042MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCNSCHERING CORP SUB SCHERING PLOUGH CORPaf843e84c58b64ec3e488bc8c2ca7c17c64e7b48bca21da145738d492b0f6dcb
106N020486001BECLOMETHASONE DIPROPIONATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONVANCERIL DOUBLE STRENGTHSCHERING0.084MG/INH[]1996-12-24Dec 24, 1996NoNoNoDISCNSCHERING CORP13ef34bac6404b2715c38d2d5c0e0a643746c5977fe98eb4cb3a5996c79dc8ea
107N018473001ALBUTEROLAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONVENTOLINGLAXOSMITHKLINE0.09MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCNGLAXOSMITHKLINE4b1ce56ecaafaa3e3e2e13c3b7d8251cd4922eb846a86ff205504397b2a290ff
108N020983001ALBUTEROL SULFATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONVENTOLIN HFAGLAXOSMITHKLINEEQ 0.09MG BASE/INHBX["BX"]2001-04-19Apr 19, 2001NoYesYesRXGLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLANDb9c7142cbdc95985763cff4aaeb4ca30551bb97c0bc41e8bc61b8ac000a010a7
109N021730001LEVALBUTEROL TARTRATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONXOPENEX HFASUNOVIONEQ 0.045MG BASE/INH[]2005-03-11Mar 11, 2005NoYesYesRXSUNOVION PHARMACEUTICALS INC5b3bcdeb0c98ab7576ecd8ff84489c0282c996cf7856da055da0adc6b1357de2
110N018584001BECLOMETHASONE DIPROPIONATEAEROSOL, METERED;NASALAEROSOL, METEREDNASALBECONASEGLAXOSMITHKLINE0.042MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCNGLAXOSMITHKLINEd9b86e8c049ff655731d941f47ba176b84c8012fac7271dfdca5529c6278b9ba
111N019798001TRIAMCINOLONE ACETONIDEAEROSOL, METERED;NASALAEROSOL, METEREDNASALNASACORTSANOFI AVENTIS US0.055MG/INH[]1991-07-11Jul 11, 1991NoNoNoDISCNSANOFI AVENTIS US LLCe55dd214187658f05148ea1ab0fc0aa6ec2e6f96c721bfe932b080756c593cd5
112N202813002BECLOMETHASONE DIPROPIONATEAEROSOL, METERED;NASALAEROSOL, METEREDNASALQNASLTEVA BRANDED PHARM0.04MG/ACTUATION[]2014-12-17Dec 17, 2014NoYesNoRXTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC2d761b1c17f37585f519127095f3c153f2783d6b98596a8054cb55408b3508c5
113N202813001BECLOMETHASONE DIPROPIONATEAEROSOL, METERED;NASALAEROSOL, METEREDNASALQNASLTEVA BRANDED PHARM0.08MG/ACTUATION[]2012-03-23Mar 23, 2012NoYesYesRXTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC334daf5aaa1f2d27d1a5b1a1df3b2aee96e2c0b975b9a28a37242a40769e64ca
114N020233001BUDESONIDEAEROSOL, METERED;NASALAEROSOL, METEREDNASALRHINOCORTASTRAZENECA0.032MG/INH[]1994-02-14Feb 14, 1994NoNoNoDISCNASTRAZENECA LP89b50b9c6ceff60d72e856047ae4f1bec5815e76b718708eb59ab6630a1fe039
115N018521001BECLOMETHASONE DIPROPIONATEAEROSOL, METERED;NASALAEROSOL, METEREDNASALVANCENASESCHERING0.042MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCNSCHERING CORP SUB SCHERING PLOUGH CORP08b9c4d8a01a7ad9c1991a0af7c6624c0147139900ed078c2ff860b68d0c3ebb
116N202129001CICLESONIDEAEROSOL, METERED;NASALAEROSOL, METEREDNASALZETONNACOVIS0.037MG/INH[]2012-01-20Jan 20, 2012NoYesYesRXCOVIS PHARMA GMBHa2e7fc078ceaf3409937141f4383a50c455b6f208548bb6238b09c4897a8cd54
117N017351001HYDROCORTISONE ACETATEAEROSOL, METERED;RECTALAEROSOL, METEREDRECTALCORTIFOAMMYLAN SPECIALITY LP10%[]1982-02-10Feb 10, 1982NoYesYesRXMYLAN SPECIALTY LPd02bc7f66116f8811fe93b8268a90fe9e20fdfae0665c1f4de4b0b29e6cc5934
118N021780001NITROGLYCERINAEROSOL, METERED;SUBLINGUALAEROSOL, METEREDSUBLINGUALNITROMISTEVUS0.4MG/SPRAY[]2006-11-02Nov 2, 2006NoYesYesRXEVUS HEALTH SOLUTIONS LLC1e2b591b5bd78f2dcf5d58dc694d487fb9ef380995c5eb92f238e27fa52543cd
119A086457001HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDEAEROSOL, METERED;TOPICALAEROSOL, METEREDTOPICALEPIFOAMMYLAN SPECIALITY LP1%;1%BX["BX"]Approved Prior to Jan 1, 1982YesNoNoRXMYLAN SPECIALTY LPb12daa876d04d0c07620ceadac0ec13d194277d990cc09811f1df4c38f26d3de
120N019127001CHLORHEXIDINE GLUCONATEAEROSOL, METERED;TOPICALAEROSOL, METEREDTOPICALEXIDINEXTTRIUM4%[]1984-12-24Dec 24, 1984NoYesYesOTCXTTRIUM LABORATORIES INC3a4b0a8a1492e0b062b2390fcda208154847e1c8983e56e20e810eec595ad765
121A089440001HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDEAEROSOL, METERED;TOPICALAEROSOL, METEREDTOPICALHYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%GENUS1%;1%[]1988-05-17May 17, 1988NoNoNoDISCNGENUS LIFESCIENCES INCa4a696dc47fb72b46ccada58ecfbf2a8b3717865efe92f3f1e49e51041cce6b9
122A086195001HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDEAEROSOL, METERED;TOPICALAEROSOL, METEREDTOPICALPROCTOFOAM HCMYLAN SPECIALITY LP1%;1%BX["BX"]Approved Prior to Jan 1, 1982YesNoNoRXMYLAN SPECIALTY LP786da2ec2846581c59b510341c50fb4c82982be99621ad18ee43e3f50e989619
123N020587001TALCAEROSOL;INTRAPLEURALAEROSOLINTRAPLEURALSCLEROSOLLYMOL MEDCL4GM/SPRAY[]1997-12-24Dec 24, 1997NoYesYesRXLYMOL MEDICAL CORP921df8edf729114561ac22bfa8279056065739bd0329e2d31409d9984f8e914c
124N014242001DEXAMETHASONE SODIUM PHOSPHATEAEROSOL;NASALAEROSOLNASALDEXACORTUCB INCEQ 0.1MG PHOSPHATE/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCNUCB INCaa419ed8297cc1e664aa0c20970e8ade16bfac22ce810eb9b049f3f57e9d7da9
125N014394001LIDOCAINEAEROSOL;ORALAEROSOLORALXYLOCAINEASTRAZENECA10%[]Approved Prior to Jan 1, 1982YesNoNoDISCNASTRAZENECA LP25aa38d139c3378b23f7731211912694a789dbad76c112e44b5131e8a55d6a06
126N018705001NITROGLYCERINAEROSOL;SUBLINGUALAEROSOLSUBLINGUALNITROLINGUALPOHL BOSKAMP0.4MG/SPRAY[]1985-10-31Oct 31, 1985NoNoNoDISCNPOHL BOSKAMP765e4dab035a337232479c55de306cf52254ce3d4d311dee1a13c674a5a9cecc
127A083296002DEXAMETHASONEAEROSOL;TOPICALAEROSOLTOPICALAEROSEB-DEXALLERGAN HERBERT0.01% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesNoNoDISCNALLERGAN HERBERT DIV ALLERGAN INC0254fc1d425b2f73be28908bd0ad978e138c70c74fcbd78955ac40c371e6218f
128A085805001HYDROCORTISONEAEROSOL;TOPICALAEROSOLTOPICALAEROSEB-HCALLERGAN HERBERT0.5%[]Approved Prior to Jan 1, 1982YesNoNoDISCNALLERGAN HERBERT DIV ALLERGAN INC54e61951a0748caba381383dd6fa7624970ef12101ff867490693d18296a46ad
129N012731002DEXAMETHASONEAEROSOL;TOPICALAEROSOLTOPICALDECASPRAYMERCK0.04% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]Approved Prior to Jan 1, 1982YesYesNoDISCNMERCK AND CO INC5e6dad4357b902c29c54f470c90ff6565d1d30c9acfdef26338ca721afaeead0
130N050167002BACITRACIN ZINC; POLYMYXIN B SULFATEAEROSOL;TOPICALAEROSOLTOPICALPOLYSPORINGLAXOSMITHKLINE10,000 UNITS/GM;2,000,000 UNITS/GM[]1985-03-01Mar 1, 1985NoNoNoDISCNGLAXOSMITHKLINEefd392d8ee3ae8c6163565746cbdbd758d6ed0eed3ebaed23b0ab12b551a0137
131N021043001PIPERONYL BUTOXIDE; PYRETHRINSAEROSOL;TOPICALAEROSOLTOPICALRID MOUSSEBAYER HEALTHCARE LLC4%;EQ 0.33% BASE[]2000-03-07Mar 7, 2000NoNoNoDISCNBAYER HEALTHCARE LLC92de9d5c334bd70350c9abb3f5e520e4f24403bde2bb651d2a3dba2cc550509c
132N017424001HEXACHLOROPHENEAEROSOL;TOPICALAEROSOLTOPICALSEPTISOLVESTAL LABS0.23%[]Approved Prior to Jan 1, 1982YesNoNoDISCNVESTAL LABORATORIES DIV CHEMED CORP7bfd585c667d45e8c4ea66fe83f1467e16d496552afd868f953b16ce42f037f4
133N018375001HEXACHLOROPHENEAEROSOL;TOPICALAEROSOLTOPICALTURGEXXTTRIUM3%[]Approved Prior to Jan 1, 1982YesNoNoDISCNXTTRIUM LABORATORIES INCe73cf7e021b7b11434e4fec0660d788ad51c64a9795e786ce3b568c3745b00b3
134N014349002NONOXYNOL-9AEROSOL;VAGINALAEROSOLVAGINALDELFENPERSONAL PRODS12.5%[]Approved Prior to Jan 1, 1982YesNoNoDISCNPERSONAL PRODUCTS CO519d30ff34f404c9fb0222f654311d9f5aa674fc585433198d8f98d86aceb669
135A071621001CHOLESTYRAMINEBAR, CHEWABLE;ORALBAR, CHEWABLEORALCHOLYBARPARKE DAVISEQ 4GM RESIN/BAR[]1988-05-26May 26, 1988NoNoNoDISCNPARKE DAVIS DIV WARNER LAMBERT COcee5fa491a10ce08c986e2d441a139daa81a0512da96260d04b989ac957c58df
136A071739001CHOLESTYRAMINEBAR, CHEWABLE;ORALBAR, CHEWABLEORALCHOLYBARPARKE DAVISEQ 4GM RESIN/BAR[]1988-05-26May 26, 1988NoNoNoDISCNPARKE DAVIS DIV WARNER LAMBERT COeb0b44cea6bbed18c288def8b2471ac271217479130410e0a03b1dad6e362f9d
137N210895001COLESEVELAM HYDROCHLORIDEBAR, CHEWABLE;ORALBAR, CHEWABLEORALWELCHOLDAIICHI SANKYO INC3.75GM[]2019-04-03Apr 3, 2019NoYesNoDISCNDAIICHI SANKYO INCb3a82e660be3e43b1fb754b85303da862722200d4ed7bd7f031e380d415c43d6
138A200218001AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLECAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORALCAPSULE, CAPSULE, DELAYED REL PELLETS, TABLETORALLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCINANI PHARMS INC500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG[]2013-08-30Aug 30, 2013NoNoNoDISCNANI PHARMACEUTICALS INC54ec1f83ad39a0c4070e2de607dae444b68c956da181a941ea49f3cac9fd9364
139A206006001AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLECAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORALCAPSULE, CAPSULE, DELAYED REL PELLETS, TABLETORALLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCINRISING500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MGAB["AB"]2016-10-07Oct 7, 2016NoNoYesRXRISING PHARMA HOLDINGS INC556525bb5f53c4ecb7e0bad36619f1b40ffb19ee89a81e66025fcee04e976060
140A202588001AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLECAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORALCAPSULE, CAPSULE, DELAYED REL PELLETS, TABLETORALLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCINSANDOZ INC500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MGAB["AB"]2014-03-04Mar 4, 2014NoNoNoRXSANDOZ INC5eea342540cb10575f2b159d882662f966b559f1e33e503c2cf00f9fe4b279ff
141N050757001AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLECAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORALCAPSULE, CAPSULE, DELAYED REL PELLETS, TABLETORALPREVPACTAKEDA PHARMS USA500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG[]1997-12-02Dec 2, 1997NoYesNoDISCNTAKEDA PHARMACEUTICALS USA INC72aa3807fd1ec6525c5099cf58353f71d44b5f0f8bba08187001e24c3e0ee951
142A063187001DOXYCYCLINE HYCLATECAPSULE, COATED PELLETS;ORALCAPSULE, COATED PELLETSORALDOXYCYCLINE HYCLATEPLIVAEQ 100MG BASE[]1992-06-30Jun 30, 1992NoNoNoDISCNPLIVA INCf01cd6a2349a922a2f7a4af68de47bbd13cfb5af2f885d5226844a7250aec97d
143N021507002LANSOPRAZOLE; NAPROXENCAPSULE, DELAYED REL PELLETS, TABLET;ORALCAPSULE, DELAYED REL PELLETS, TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)TAKEDA PHARMS NA15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]2003-11-14Nov 14, 2003NoYesNoDISCNTAKEDA PHARMACEUTICALS NORTH AMERICA INCcb875a78bf63574051f6899d78cab4d144a9b17390da3e7c143415e3975ed2cb
144N021507003LANSOPRAZOLE; NAPROXENCAPSULE, DELAYED REL PELLETS, TABLET;ORALCAPSULE, DELAYED REL PELLETS, TABLETORALPREVACID NAPRAPAC 375 (COPACKAGED)TAKEDA PHARMS NA15MG,N/A;N/A,375MG[]2003-11-14Nov 14, 2003NoNoNoDISCNTAKEDA PHARMACEUTICALS NORTH AMERICA INC332a9b59c7ebc2c4ffc13f33bcd21581b15658d336986515ea736a6fd7beb755
145N021507004LANSOPRAZOLE; NAPROXENCAPSULE, DELAYED REL PELLETS, TABLET;ORALCAPSULE, DELAYED REL PELLETS, TABLETORALPREVACID NAPRAPAC 500 (COPACKAGED)TAKEDA PHARMS NA15MG,N/A;N/A,500MG[]2003-11-14Nov 14, 2003NoNoNoDISCNTAKEDA PHARMACEUTICALS NORTH AMERICA INCed237efb6b1ee48f9297b2ed412a17f17613be2216feed677d1721e5db0d8168
146N021427001DULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALCYMBALTALILLYEQ 20MG BASEAB["AB"]2004-08-03Aug 3, 2004NoYesNoRXELI LILLY AND CO046a952be806e9b2f8933684db262158bcc64df6e386f7fdfea35c6a8f730990
147N021427002DULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALCYMBALTALILLYEQ 30MG BASEAB["AB"]2004-08-03Aug 3, 2004NoYesNoRXELI LILLY AND COdd1030111e4827efe3b2a98541975eaef158a6cadfc4b14ac8cde73ca21471a9
148N021427004DULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALCYMBALTALILLYEQ 60MG BASEAB["AB"]2004-08-03Aug 3, 2004NoYesYesRXELI LILLY AND CO53e1fa9e560f0144a47a54f359ebe70f49578075b22d7656c461b7288f48709e
149N019680001DIVALPROEX SODIUMCAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALDEPAKOTEABBVIEEQ 125MG VALPROIC ACIDAB["AB"]1989-09-12Sep 12, 1989NoYesYesRXABBVIE INCa82ad1700a73e5c84a18711cd310c80f86647b36f70cad6d772ce594a54aeb85
150A090094001DIDANOSINECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALDIDANOSINEAUROBINDO PHARMA125MG[]2008-09-24Sep 24, 2008NoNoNoDISCNAUROBINDO PHARMA LTDae3bdc3daef2a393bd41ce878d96fa46ebb5ceb200248a4c41c719489701661d
151A090094002DIDANOSINECAPSULE, DELAYED REL PELLETS;ORALCAPSULE, DELAYED REL PELLETSORALDIDANOSINEAUROBINDO PHARMA200MG[]2008-09-24Sep 24, 2008NoNoNoDISCNAUROBINDO PHARMA LTD6fc749c1a2fc2f1b75e27972275e7cf952be5236ec576c2b4afc095408a1f20d