← Snapshot 21

Orange Book snapshot 21: Products

Products page 2 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
52N205641003MOMETASONE FUROATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONASMANEX HFAMERCK SHARP DOHME0.05MG/INH[]2019-08-12Aug 12, 2019NoYesNoRXMERCK SHARP AND DOHME CORP07670c8739265ffbfcf76103d1adc37b423ef22ce11c9ecb05411545d2abc9f5
53N205641001MOMETASONE FUROATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONASMANEX HFAMERCK SHARP DOHME0.10MG/INH[]2014-04-25Apr 25, 2014NoYesNoRXMERCK SHARP AND DOHME CORP7de44f4cbc230ec2b5573c2756c6c96101ddfb8cac7c2e83bb917fdf76b1d322
54N205641002MOMETASONE FUROATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONASMANEX HFAMERCK SHARP DOHME0.20MG/INH[]2014-04-25Apr 25, 2014NoYesYesRXMERCK SHARP AND DOHME CORPd28c925f33d5c34c297ff864bd3f4ccfe7192a2de6d27c7d23c8300d29c6cd53
55N020056001ATROPINE SULFATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONATROPINE SULFATEUS ARMYEQ 0.36MG BASE/INH[]1990-09-19Sep 19, 1990NoNoNoDISCNUNITED STATES ARMY OFFICE SURGEON GENERAL158d9b3b093d78ccfbece5de4bb55fdf1746e405dc0b5fbd855fefbfd59588d4
56N019085001IPRATROPIUM BROMIDEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONATROVENTBOEHRINGER INGELHEIM0.018MG/INH[]1986-12-29Dec 29, 1986NoNoNoDISCNBOEHRINGER INGELHEIM PHARMACEUTICALS INCf6246e1b2c6f617e0ac4b4eaf250e877246e2228981bee0f60e88f55e1eb9cc8
57N021527001IPRATROPIUM BROMIDEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONATROVENT HFABOEHRINGER INGELHEIM0.021MG/INH[]2004-11-27Nov 27, 2004NoYesYesRXBOEHRINGER INGELHEIM PHARMACEUTICALS INCc633d6297b18fae9b25af5ca6b4b6903ce0ad9fda3ef4856fb303ccf2a501e68
58N018117001TRIAMCINOLONE ACETONIDEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONAZMACORTABBVIE0.1MG/INH[]1982-04-23Apr 23, 1982NoNoNoDISCNABBVIE INC4bd4d59f6c473cda64e65d547b26a1cac9bf681ec05ad2ef3ac33d8f62275a0b
59N018153001BECLOMETHASONE DIPROPIONATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONBECLOVENTGLAXOSMITHKLINE0.042MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCNGLAXOSMITHKLINEb18b2906bcb4ce8f2d04e83634c313b493e8dbb5fdd22f37d1bf0500f1c16d97
60N208294001FORMOTEROL FUMARATE; GLYCOPYRROLATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONBEVESPI AEROSPHEREASTRAZENECA0.0048MG/INH;0.0090MG/INH[]2016-04-25Apr 25, 2016NoYesYesRXASTRAZENECA PHARMACEUTICALS LPa36d0339d8d25b3325641ac680d4e9bda4ecb300b0e01b1b1b0381a55b6407a9
61N018762001TERBUTALINE SULFATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONBRETHAIRENOVARTIS0.2MG/INH[]1984-08-17Aug 17, 1984NoNoNoDISCNNOVARTIS PHARMACEUTICALS CORP3d27fcab338f2c37dd2ddc4cb77855ce1fc687504ce2f3f89e768907e5d21782
62N212122001BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONBREZTRI AEROSPHEREASTRAZENECA AB0.16MG/INH;0.0048MG/INH;0.009MG/INH[]2020-07-23Jul 23, 2020NoYesYesRXASTRAZENECA AB5afe38d14d94a2ebfaa80c4fb9bd803b6181681d698a4eae71a490861cc40714
63N018000001TERBUTALINE SULFATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONBRICANYLSANOFI AVENTIS US0.2MG/INH[]1985-03-19Mar 19, 1985NoNoNoDISCNSANOFI AVENTIS US LLC22a2d8b7faae1f685ae8e6af4b5bebad0b245b396b5cf4ca87907209bbbe8c7b
64N019912001SODIUM CHLORIDEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONBRONCHO SALINEBLAIREX0.9%[]1992-09-03Sep 3, 1992NoYesYesOTCBLAIREX LABORATORIES INC1e4e4b7961f456293434624eba4ef8d0e359b6b9f7eb3ffd51a6e5783bca7218
65N016126002EPINEPHRINE BITARTRATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONBRONITIN MISTWYETH CONS0.3MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCNWYETH CONSUMER HEALTHCARE753fe4e7ad5ddc2b51f32d275e8cb3afb704df68ff01d63953ccb444fe643e27
66N016803001EPINEPHRINEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONBRONKAID MISTSTERLING0.25MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCNSTERLING HEALTH DIV STERLING WINTHROP INCcbfae2f51999c31a780c7e83f5bd9360615eb1d7166e8a93d3ba88f536c28f88
67N012339007ISOETHARINE MESYLATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONBRONKOMETERSANOFI AVENTIS US0.34MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCNSANOFI AVENTIS US LLC0d5564a0caff1c718674906870e933edf94e243ac037234e505a1d3b0f18ef54
68N020291001ALBUTEROL SULFATE; IPRATROPIUM BROMIDEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONCOMBIVENTBOEHRINGER INGELHEIMEQ 0.09MG BASE/INH;0.018MG/INH[]1996-10-24Oct 24, 1996NoNoNoDISCNBOEHRINGER INGELHEIM PHARMACEUTICALS INC45502f8b217dc89e66d32c2505038bcb836618c0ccc782d8ca4c36f4d7f5a798
69N013413001DEXAMETHASONE SODIUM PHOSPHATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONDEXACORTUCB INCEQ 0.1MG PHOSPHATE/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCNUCB INC7de4334bb627a0d9210fa4be470e7e969d2126cb2da8775c58b909df819dc7bd
70N022518003FORMOTEROL FUMARATE; MOMETASONE FUROATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONDULERAMERCK SHARP DOHME0.005MG/INH;0.05MG/INH[]2019-08-12Aug 12, 2019NoYesNoRXMERCK SHARP AND DOHME CORP35827da6cb7caac52429ee66b426e4dba56fbdd2c8843d83460e2b69d71ac200
71N022518001FORMOTEROL FUMARATE; MOMETASONE FUROATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONDULERAMERCK SHARP DOHME0.005MG/INH;0.1MG/INH[]2010-06-22Jun 22, 2010NoYesYesRXMERCK SHARP AND DOHME CORP305ed4c43fb45f47cafd374c7e5b27e8b0e79ae3e734ca6aeaa494f0545b79e8
72N022518002FORMOTEROL FUMARATE; MOMETASONE FUROATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONDULERAMERCK SHARP DOHME0.005MG/INH;0.2MG/INH[]2010-06-22Jun 22, 2010NoYesYesRXMERCK SHARP AND DOHME CORP07535760188ff6c461bb76e328b92f0f6de143d90dba5b0c5be97e3ee8da45e4
73N013296001ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONDUO-MEDIHALER3M0.16MG/INH;0.24MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCN3M PHARMACEUTICALS INC945c1772ca928d5d6f62f0fbf379d8eebe09185ad5773f25a922105ceeb8c551
74A087907001EPINEPHRINEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONEPINEPHRINEARMSTRONG PHARMS0.2MG/INH[]1984-05-23May 23, 1984NoNoNoDISCNARMSTRONG PHARMACEUTICALS INC3cb1a77354949245035592ad97109bde626d319de6d5fbac654ce7f15513708a
75N020548001FLUTICASONE PROPIONATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONFLOVENTGLAXOSMITHKLINE0.044MG/INH[]1996-03-27Mar 27, 1996NoNoNoDISCNGLAXOSMITHKLINE8f55d01480c3a178d58a7c744633b8abd116b15edcb96dce7cb8ec3783091626
76N020548002FLUTICASONE PROPIONATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONFLOVENTGLAXOSMITHKLINE0.11MG/INH[]1996-03-27Mar 27, 1996NoNoNoDISCNGLAXOSMITHKLINE7aa8235602f25da38c80afde7e13b3b22f4ce401fd17e78361ece465767fa2df
77N020548003FLUTICASONE PROPIONATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONFLOVENTGLAXOSMITHKLINE0.22MG/INH[]1996-03-27Mar 27, 1996NoNoNoDISCNGLAXOSMITHKLINEcd7b83b751c44191691200d573f8db3662c1f911d7b97397f5ca5bfa75f2c00c
78N021433003FLUTICASONE PROPIONATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONFLOVENT HFAGLAXO GRP LTD0.044MG/INH[]2004-05-14May 14, 2004NoYesYesRXGLAXO GROUP LTD DBA GLAXOSMITHKLINE82e47748db72da754ea28552d9a4606712aad537f78d2d538671c67bdfbaf0db
79N021433002FLUTICASONE PROPIONATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONFLOVENT HFAGLAXO GRP LTD0.11MG/INH[]2004-05-14May 14, 2004NoYesYesRXGLAXO GROUP LTD DBA GLAXOSMITHKLINE290f58d833ff33096179b57d0936b130e89f1f2a21d1d507878bf9c14b41c47a
80N021433001FLUTICASONE PROPIONATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONFLOVENT HFAGLAXO GRP LTD0.22MG/INH[]2004-05-14May 14, 2004NoYesYesRXGLAXO GROUP LTD DBA GLAXOSMITHKLINEe30e85b1008a42bbeeb1a12acbe08e38d5d817542a7c2ee7efd8893d20f68f26
81N018887001CROMOLYN SODIUMAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONINTALKING PHARMS LLC0.8MG/INH[]1985-12-05Dec 5, 1985NoNoNoDISCNKING PHARMACEUTICALS LLCae301ae7fb010ca9e776e33e36d846fe767c363f7d6ceb6be30994cc5dc80f51
82A087858001ISOETHARINE MESYLATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONISOETHARINE MESYLATEALPHARMA US PHARMS0.34MG/INH[]1984-08-21Aug 21, 1984NoNoNoDISCNALPHARMA US PHARMACEUTICALS DIVISION49e15d45fac829491902b6b556631ff320eed8f30741d2dab325832dfb055b35
83N010375004ISOPROTERENOL HYDROCHLORIDEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONISOPROTERENOL HYDROCHLORIDE3M0.12MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCN3M PHARMACEUTICALS INC821936a84ec4f33753cd4887c29af1f7e4504897ab43bae2f638cba96998571c
84A085904001ISOPROTERENOL HYDROCHLORIDEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONISOPROTERENOL HYDROCHLORIDEALPHARMA US PHARMS0.12MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCNALPHARMA US PHARMACEUTICALS DIVISION5a19e3ce865b85adb2f54054a6d710727d721b5a1f65b6db5ef9571e5ff7374c
85N011178001ISOPROTERENOL HYDROCHLORIDEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONISUPRELSANOFI AVENTIS US0.103MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCNSANOFI AVENTIS US LLC927247afbd49e6e7372f14d0e03e57ef971b4d249e31804715857f27fb6af1cd
86N019009001PIRBUTEROL ACETATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONMAXAIRBAUSCHEQ 0.2MG BASE/INH[]1986-12-30Dec 30, 1986NoNoNoDISCNBAUSCH HEALTH US LLCcc7002b08f26291ff96aadadee711a54c61ce7ab4d6984661cfd45e2b360e57a
87N020014001PIRBUTEROL ACETATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONMAXAIRMEDICISEQ 0.2MG BASE/INH[]1992-11-30Nov 30, 1992NoNoNoDISCNMEDICIS PHARMACEUTICAL CORP3e05de98a5119cc0c176e74609db57b929a41c7ca1bab9f40da380f883a7510a
88N012102001ERGOTAMINE TARTRATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONMEDIHALER ERGOTAMINE3M0.36MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCN3M PHARMACEUTICALS INCd14956a92829aec0abcba0e047cdee2c559af4d856ef53bfbdae7eccb173f4cd
89N010374003EPINEPHRINE BITARTRATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONMEDIHALER-EPI3M0.3MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCN3M PHARMACEUTICALS INCaaae70e26912b79a74b7b0e85764aae8ca2bb2d3cbee81efc7fea0342faae9c2
90N010375003ISOPROTERENOL SULFATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONMEDIHALER-ISO3M0.08MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCN3M PHARMACEUTICALS INC12d7cfa6baf9876779e4272da29d6a959c443ee5e865e81a4106ddfe2611e44d
91N205920001EPINEPHRINEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONPRIMATENE MISTARMSTRONG PHARMS0.125MG/INH[]2018-11-07Nov 7, 2018NoYesYesOTCARMSTRONG PHARMACEUTICALS INC51267a23ee4a4b1a47ed8d70a6570c861f03e348b59454212fa1b7ae3199f8f2
92N016126001EPINEPHRINEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONPRIMATENE MISTWYETH CONS0.2MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCNWYETH CONSUMER HEALTHCARE8383f666841fdd2bca73becf129c457ec787c9d6c2193ddb6f52abb593cb92d8
93N021457001ALBUTEROL SULFATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONPROAIR HFATEVA BRANDED PHARMEQ 0.09MG BASE/INHAB2["AB2"]2004-10-29Oct 29, 2004NoYesYesRXTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC5f292562d8c921eb2679c123dd2be1eb1a53298155b3c765f1a1064a1db635e8
94N017559001ALBUTEROLAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONPROVENTILSCHERING0.09MG/INH[]Approved Prior to Jan 1, 1982YesNoNoDISCNSCHERING CORP SUB SCHERING PLOUGH CORP9ebcd40f2f1ac43433dbd28235054e0c59ef5860e8c0f3b007449dab5317a599
95N020503001ALBUTEROL SULFATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONPROVENTIL-HFAKINDEVAEQ 0.09MG BASE/INHAB1["AB1"]1996-08-15Aug 15, 1996NoYesYesRXKINDEVA DRUG DELIVERY LPdbc9c9e0a3d3fdace56de3cacb57df2495bffed98da81323069187108a85afa1
96N020911002BECLOMETHASONE DIPROPIONATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONQVAR 40TEVA BRANDED PHARM0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]2000-09-15Sep 15, 2000NoYesNoDISCNTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INCcf53fb80541ab65ea2e457246db18a5ea29a52f8333c1c7a7ec45f7d11d9d316
97N020911001BECLOMETHASONE DIPROPIONATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONQVAR 80TEVA BRANDED PHARM0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]2000-09-15Sep 15, 2000NoYesNoDISCNTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC4dc0d599b1f0f69ca15eb28841621776fe9e94cd6fa827c2efef20d82cc8ccc8
98N207921001BECLOMETHASONE DIPROPIONATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONQVAR REDIHALERNORTON WATERFORD0.04MG/INH[]2017-08-03Aug 3, 2017NoYesNoRXNORTON WATERFORD LTD5d80cf80bbae8b1844784cce04d2d4b2e9e87d23f9b440c896f5570c52a52b6b
99N207921002BECLOMETHASONE DIPROPIONATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONQVAR REDIHALERNORTON WATERFORD0.08MG/INH[]2017-08-03Aug 3, 2017NoYesNoRXNORTON WATERFORD LTD38d52c37e341a3d529a8510960e49a87b46c77a5de0f2f47d3693f2abef46782
100N020236001SALMETEROL XINAFOATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONSEREVENTGLAXOSMITHKLINEEQ 0.021MG BASE/INH[]1994-02-04Feb 4, 1994NoNoNoDISCNGLAXOSMITHKLINE75c4e8f6c8b419ac86d9ea64b708a78075f6e71c58374619a41c3810cf4335ae
101N021929001BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATEAEROSOL, METERED;INHALATIONAEROSOL, METEREDINHALATIONSYMBICORTASTRAZENECA0.08MG/INH;0.0045MG/INH[]2006-07-21Jul 21, 2006NoYesYesRXASTRAZENECA LPd3588ac244f3b65e507346234c7ca197df604eb93f331537ef2503c47e4a18fc