Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10056047serious1Date Last Updated03/04/2014receiptdateformat102companynumbUS-SA-2014SA036256occurcountryUSduplicate1Date Received03/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age58Unit of Onset AgeyearsWeight105.2SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionLymphadenitis bacterialOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionCellulitisOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionCellulitis streptococcalOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionOsteoarthritisOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionPainOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionArthralgiaOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionFatigueOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionSleep disorderOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionArthropathyOutcomeUnknown

10)

reactionmeddraversionpt17.0ReactionRashOutcomeRecovered/resolved

11)

reactionmeddraversionpt17.0ReactionDry eyeOutcomeUnknown

12)

reactionmeddraversionpt17.0ReactionTinnitusOutcomeUnknown

13)

reactionmeddraversionpt17.0ReactionDry mouthOutcomeUnknown

14)

reactionmeddraversionpt17.0ReactionCoughOutcomeRecovered/resolved

15)

reactionmeddraversionpt17.0ReactionDyspepsiaOutcomeRecovered/resolved

16)

reactionmeddraversionpt17.0ReactionMyalgiaOutcomeUnknown

17)

reactionmeddraversionpt17.0ReactionMuscular weaknessOutcomeUnknown

18)

reactionmeddraversionpt17.0ReactionPolydipsiaOutcomeUnknown

19)

reactionmeddraversionpt17.0ReactionPolyuriaOutcomeUnknown

20)

reactionmeddraversionpt17.0ReactionLymph node painOutcomeUnknown

21)

reactionmeddraversionpt17.0ReactionJoint stiffnessOutcomeUnknown

22)

reactionmeddraversionpt17.0ReactionJoint swellingOutcomeUnknown

23)

reactionmeddraversionpt17.0ReactionHypoaesthesiaOutcomeUnknown

24)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeUnknown

25)

reactionmeddraversionpt17.0ReactionBlood glucose abnormalOutcomeUnknown

26)

reactionmeddraversionpt17.0ReactionChest painOutcomeRecovered/resolved

27)

reactionmeddraversionpt17.0ReactionLymphadenopathyOutcomeUnknown

28)

reactionmeddraversionpt17.0ReactionNeuropathy peripheralOutcomeRecovering/resolving

29)

reactionmeddraversionpt17.0ReactionPyrexiaOutcomeRecovered/resolved

30)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeRecovered/resolved

31)

reactionmeddraversionpt17.0ReactionVomitingOutcomeRecovered/resolved

32)

reactionmeddraversionpt17.0ReactionDiarrhoeaOutcomeUnknown

33)

reactionmeddraversionpt17.0ReactionNauseaOutcomeRecovered/resolved

34)

reactionmeddraversionpt17.0ReactionAlopeciaOutcomeUnknown

35)

reactionmeddraversionpt17.0ReactionMouth ulcerationOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductARAVAdrugbatchnumbUNKNOWNdrugauthorizationnumb020905drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

openFDA Info on Medication

Application NumberNDA020905Brand NameARAVAGeneric NameLEFLUNOMIDEManufacturerssanofi-aventis U.S. LLCproduct_ndc0088-2160, 0088-2161, 0088-2162Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEFLUNOMIDERXCUI205284, 205285, 205286, 213377, 213379, 213380spl_idf52c3d5c-6d99-402a-a658-915601216318spl_set_id320f63f2-fac3-4aee-aff8-85724e00ef52Package NDC0088-2160-30, 0088-2161-30, 0088-2162-33NUIN0000175713Established Pharmacologic ClassAntirheumatic Agent [EPC]UNIIG162GK9U4W

2)

drugcharacterization1medicinalproductENBRELdrugbatchnumb1034020drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetextSOLUTION FOR INJECTION IN PREFILLED SYRINGEdrugdosageformSOLUTION FOR INJECTIONdrugadministrationroute058drugindicationRHEUMATOID ARTHRITISdrugstartdateformat102drugstartdate01/05/2012drugenddateformat102drugenddate19/02/2013actiondrug1

openFDA Info on Medication

Application NumberBLA103795Brand NameENBRELGeneric NameETANERCEPTManufacturersImmunex Corporationproduct_ndc 58406-010, 58406-435, 58406-445, 58406-425, 58406-455, 58406-456, 58406-446, 584 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsETANERCEPTRXCUI 253014, 261105, 727757, 802652, 809158, 809159, 1653223, 1653225, 2182338, 21823 ... spl_id2ba5b73d-d161-42a8-94d1-2bdd101b2e98spl_set_ida002b40c-097d-47a5-957f-7a7b1807af7fPackage NDC 58406-435-01, 58406-435-04, 58406-445-01, 58406-445-04, 58406-425-41, 58406-425- ... NUIN0000175610, N0000175451Established Pharmacologic ClassTumor Necrosis Factor Blocker [EPC]Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity [MoA]UNIIOP401G7OJC

3)

drugcharacterization2medicinalproductBACTROBANdrugdosageformOINTMENT

4)

drugcharacterization2medicinalproductNEXIUMdrugdosageformCAPSULE

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id416c365d-7271-4804-9285-643858cf578b, ac4ba22b-f431-4ab4-b239-0e220ad804ddspl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

5)

drugcharacterization2medicinalproductDICLOFENAC SODIUMdrugdosageformTABLETdrugstartdateformat102drugstartdate11/04/2013

openFDA Info on Medication

Application Number ANDA203818, ANDA204306, ANDA202769, ANDA204132, ANDA210986, ANDA211253, ANDA2058 ... Brand Name DICLOFENAC SODIUM, GOOD NEIGHBOR PHARMACY ARTHRITIS PAIN, SIGNATURE CARE ARTHRIT ... Generic Name DICLOFENAC SODIUM, DICLOFENAC, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC SOD ... Manufacturers IPG PHARMACEUTICALS, INC., Mylan Pharmaceuticals Inc., Teligent Pharma, Inc., Lu ... product_ndc 71085-002, 0378-8750, 52565-002, 68180-538, 21922-044, 46122-646, 40032-016, 684 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteTOPICAL, TRANSDERMAL, ORAL, OPHTHALMICActive IngredientsDICLOFENAC SODIUMRXCUI 857700, 855633, 855642, 1487074, 1487076, 855644, 855906, 855926, 855635, 854801 ... spl_id aa6f3401-4aad-43cc-9e01-12ffaf89a0ac, 7f7def3c-80d9-498d-8be4-d6525e81ee48, 7a09 ... spl_set_id f491253d-14ab-4063-b57f-eb9254c1d833, 585549fe-dca3-47cb-a454-7a3b42fa8443, 5960 ... Package NDC 71085-002-05, 0378-8750-06, 52565-002-05, 68180-538-01, 21922-044-09, 21922-044- ... UNIIQTG126297Q

6)

drugcharacterization2medicinalproductPATANOL

openFDA Info on Medication

Application NumberNDA020688Brand NamePATANOLGeneric NameOLOPATADINE HYDROCHLORIDEManufacturersAlcon Laboratories, Inc.product_ndc0065-0271Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMICActive IngredientsOLOPATADINE HYDROCHLORIDERXCUI1111339, 1111341spl_id144a0240-0655-4a63-aee2-e6d4e563a378spl_set_ideae41728-12e3-4bde-a6bb-b384a5cbae41Package NDC0065-0271-05UNII2XG66W44KF

7)

drugcharacterization2medicinalproductIMMUNOGLOBULIN G HUMAN

8)

drugcharacterization2medicinalproductSERTRALINE HYDROCHLORIDEdrugdosageformTABLET

openFDA Info on Medication

Application Number ANDA077206, NDA020990, NDA019839, ANDA078861, ANDA077864, ANDA077106, ANDA076934 ... Brand NameSERTRALINE HYDROCHLORIDE, SERTRALINE, ZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturers Aurobindo Pharma Limited, Greenstone LLC, Rising Pharmaceuticals, Inc., Hikma Ph ... product_ndc 65862-011, 65862-012, 65862-013, 59762-0067, 59762-4960, 59762-4900, 59762-4910, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941, 861064, 208149, 208161, 212233, 861066spl_id 80aac5d8-bb02-46f5-a8ca-5fc9f934541c, 1ef7897d-60bb-4685-820f-21c78a097642, 96aa ... spl_set_id 39a85db1-9e59-4ab0-9e18-36757f019faa, 1a58062b-e635-431a-908d-2651c6a4a21c, af2c ... Package NDC 65862-011-30, 65862-011-50, 65862-011-60, 65862-011-90, 65862-011-01, 65862-011- ... UNIIUTI8907Y6X

9)

drugcharacterization2medicinalproductLEVOCETIRIZINE DIHYDROCHLORIDEdrugdosageformTABLET

openFDA Info on Medication

Application Number ANDA211983, ANDA203646, ANDA211551, ANDA204599, ANDA202046, ANDA205564, ANDA2026 ... Brand Name GOOD SENSE LEVOCETIRIZINE, LEVOCETIRIZINE DIHYDROCHLORIDE, ALLERGY RELIEF 24HR, ... Generic NameLEVOCETIRIZINE DIHYDROCHLORIDEManufacturers L. Perrigo Company, YILING PHARMACEUTICAL, INC., Vitesse Pharma LLC, Walgreen Co ... product_ndc 0113-0241, 69117-1000, 73226-001, 0363-2241, 0527-1917, 10135-639, 72559-007, 33 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOCETIRIZINE DIHYDROCHLORIDERXCUI855172, 855168, 855174, 855170spl_id 0b482364-a00a-4b95-975a-f403a3ae4d2e, 9c134fe5-26a3-6bb3-e053-2995a90a2ceb, b8a3 ... spl_set_id 0b482364-a00a-4b95-975a-f403a3ae4d2e, 4aa6f67e-5331-661b-e054-00144ff88e88, 6407 ... Package NDC 0113-0241-01, 69117-1000-1, 73226-001-00, 0363-2241-76, 0527-1917-69, 10135-639- ... UNIISOD6A38AGA

10)

drugcharacterization2medicinalproductDIAZEPAMdrugdosageformTABLET

openFDA Info on Medication

Application Number ANDA072079, ANDA071134, ANDA071135, ANDA071136, NDA020124, ANDA210363, NDA020648 ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Mayne Pharma, Meridian Medical Technologies, Inc., Dash Pharmaceu ... product_ndc 0409-1273, 51862-062, 51862-063, 51862-064, 11704-600, 69339-136, 66490-650, 686 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORAL, RECTAL, NASALActive IngredientsDIAZEPAMRXCUI 1807459, 197589, 197590, 197591, 1807452, 2120550, 801957, 801961, 801966, 22726 ... spl_id c2374258-57c6-4be5-89df-27d6cf5dc832, 49cd2631-74e5-4291-a491-b15b2fa31ee3, 8861 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, 7d81850c-ad3f-4e2e-ac41-ed9c567aea4b, fa35 ... Package NDC 0409-1273-03, 0409-1273-32, 51862-062-01, 51862-062-05, 51862-062-10, 51862-063- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

11)

drugcharacterization2medicinalproductADVAIR

openFDA Info on Medication

Application NumberNDA021077Brand NameADVAIR DISKUSGeneric NameFLUTICASONE PROPIONATE AND SALMETEROLManufacturersGlaxoSmithKline LLCproduct_ndc0173-0695, 0173-0696, 0173-0697Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsSALMETEROL XINAFOATE, FLUTICASONE PROPIONATERXCUI 896161, 896165, 896184, 896185, 896186, 896190, 896209, 896212, 896218, 896222, ... spl_idc03442a4-17dc-4c49-ae07-3f8f7f26e0dfspl_set_id4eeb5f6a-593f-4a9e-9692-adefa2caf8fcPackage NDC 0173-0695-00, 0173-0695-04, 0173-0696-00, 0173-0696-04, 0173-0697-00, 0173-0697- ... UNIIO2GMZ0LF5W, 6EW8Q962A5

12)

drugcharacterization2medicinalproductZYRTECdrugdosageformCAPSULE

openFDA Info on Medication

Application NumberNDA022429Brand NameZYRTECGeneric NameCETIRIZINE HYDROCHLORIDEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-779Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI1014675, 1020023spl_idd7532844-79d8-4648-ab9b-e5d3d3ad76f9spl_set_id605adf29-734f-451a-8ff3-74be7b5814a6Package NDC50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65UNII64O047KTOA

13)

drugcharacterization2medicinalproductALL OTHER THERAPEUTIC PRODUCTSdrugdosageformCAPSULE

14)

drugcharacterization2medicinalproductVITAMIN DdrugdosageformCAPSULE

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

15)

drugcharacterization2medicinalproductVITAMIN EdrugdosageformCAPSULE

16)

drugcharacterization2medicinalproductVITAMIN CdrugdosageformTABLET

17)

drugcharacterization2medicinalproductCALCIUM/VITAMIN DdrugdosageformTABLET

18)

drugcharacterization2medicinalproductMUCINEXdrugdosageformTABLET

openFDA Info on Medication

Application NumberNDA021282, part341Brand NameMUCINEX, MUCINEX MAXIMUM STRENGTH, MUCINEX FAST-MAX SEVERE COLDGeneric Name GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHEN ... ManufacturersRB Health (US) LLCproduct_ndc63824-008, 63824-023, 63824-020Product TypeHUMAN OTC DRUGRouteORALActive Ingredients GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCH ... RXCUI636522, 891301, 310621, 891297, 1116572spl_id a41a03f3-908a-4f4d-a456-d5e3696f6f01, 28208539-5a7e-4abe-8eea-02323da52933, 4dca ... spl_set_id dd379cdd-90ab-42e0-ad89-f50d3220f611, 47f5323c-ee3a-400d-b133-31d9c286fafd, bee0 ... Package NDC 63824-008-36, 63824-008-32, 63824-008-34, 63824-008-69, 63824-008-27, 63824-008- ... UNII495W7451VQ, 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ

19)

drugcharacterization2medicinalproductCICLESONIDE

openFDA Info on Medication

Application NumberNDA021658, NDA202129, NDA022004Brand NameALVESCO, ZETONNA, OMNARISGeneric NameCICLESONIDEManufacturersCovis Pharmaproduct_ndc70515-711, 70515-712, 70515-737, 70515-701Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION), NASALActive IngredientsCICLESONIDERXCUI799034, 799037, 799038, 799040, 1797838, 1797840, 1797841, 1797843spl_id 5246fe59-7d3c-420d-b2c2-86f9a52d204a, e8b70254-9454-45e7-bd79-c99e1812aa5f, 719d ... spl_set_id 9f6112fb-78ef-43cf-8ae3-36370eb45468, f0316d1b-9ba8-4ef3-9802-4cfed5d91d55, 15fe ... Package NDC 70515-711-01, 70515-711-02, 70515-711-03, 70515-711-04, 70515-711-05, 70515-712- ... UNIIS59502J185

20)

drugcharacterization2medicinalproductLEVOTHYROXINE SODIUMdrugdosageformTABLET

openFDA Info on Medication

Application Number ANDA209713, NDA021924, NDA021292, ANDA212399, NDA202231, NDA021342, ANDA208749, ... Brand Name LEVOTHYROXINE SODIUM, EUTHYROX, TIROSINT, LEVO-T, THYQUIDITY, LEVOXYL, UNITHROID ... Generic NameLEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUSManufacturers Lupin Pharmaceuticals, Inc., Lannett Company, Inc., Provell Pharmaceuticals, LLC ... product_ndc 68180-965, 68180-966, 68180-967, 68180-968, 68180-969, 68180-970, 68180-971, 681 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsLEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUSRXCUI 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, ... spl_id 9c2dfcdd-dc8c-4b32-9e9c-19087205679f, 8c338424-2ed3-45de-87cd-cef28456c4c1, 0b57 ... spl_set_id 18717e58-89fb-4e2f-93b6-d6ac3e988d37, 686ba2cf-7651-44de-9b4d-eeaaf2a0e364, bc3c ... Package NDC 68180-965-01, 68180-965-02, 68180-965-03, 68180-965-09, 68180-966-01, 68180-966- ... UNII9J765S329G, 054I36CPMN

21)

drugcharacterization2medicinalproductSUDAFEDdrugdosageformTABLET

openFDA Info on Medication

Application NumberNDA020021, part341Brand NameSUDAFED 24 HOUR, SUDAFEDGeneric NamePSEUDOEPHEDRINE HYDROCHLORIDEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-669, 50580-545Product TypeHUMAN OTC DRUGRouteORALActive IngredientsPSEUDOEPHEDRINE HYDROCHLORIDERXCUI1049670, 1049672, 1049160, 1049529spl_id6a06fbd9-c10d-43a4-9a6e-be1720992624, 0243c7ca-77fa-4189-bce2-ada15361b6cbspl_set_id9991599a-b49b-4ea6-a6e1-c05f0c992f71, d280abe9-6bdf-4e1e-a0cf-95fd0451c999Package NDC50580-669-10, 50580-545-24, 50580-545-72, 50580-545-48UNII6V9V2RYJ8N

22)

drugcharacterization2medicinalproductOLOPATADINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA209919, NDA021545, NDA021861, ANDA209995, ANDA204812, ANDA204723, ANDA202853 ... Brand Name OLOPATADINE HYDROCHLORIDE, PATADAY, OLOPATADINE, PATANASE, PATADAY ONCE DAILY RE ... Generic Name OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE NASAL, OLOPATADINE HYDROCHL ... Manufacturers Alembic Pharmaceuticals Inc., Alcon Laboratories, Inc., Sandoz Inc, Aurohealth L ... product_ndc 62332-501, 0065-0272, 61314-320, 58602-007, 30142-026, 72036-008, 17478-305, 458 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteOPHTHALMIC, NASALActive IngredientsOLOPATADINE HYDROCHLORIDE, OLOPATADINERXCUI 1111339, 1111343, 1111345, 1797895, 1797898, 1111341, 1601086, 1601091, 2474007, ... spl_id fc73fdb0-aa8b-4b81-998e-b1739c93047e, 593964bd-f972-427b-8b11-802c94ca2b11, 519e ... spl_set_id 7b36e554-d68a-47e0-bf3c-f4cfdc3746b6, e1eb5130-e59d-4590-8b04-7b1a6adae5bd, 6393 ... Package NDC 62332-501-05, 0065-0272-25, 0065-0272-11, 61314-320-01, 58602-007-39, 58602-007- ... UNII2XG66W44KF, D27V6190PMNUIN0000175628, N0000000190, N0000175519Physiologic/Pharmacodynamic EffectDecreased Histamine Release [PE]Mechanism of ActionHistamine H1 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-1 Receptor Inhibitor [EPC]

23)

drugcharacterization2medicinalproductPARACETAMOL/TRAMADOL HYDROCHLORIDEdrugdosageformTABLETdrugstartdateformat102drugstartdate16/01/2014

24)

drugcharacterization2medicinalproductFLUTICASONE FUROATE

openFDA Info on Medication

Application NumberNDA022051, NDA205625Brand NameFLONASE SENSIMIST ALLERGY RELIEF, ARNUITY ELLIPTAGeneric NameFLUTICASONE FUROATEManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLC, GlaxoSmithKline LLCproduct_ndc0135-0616, 0135-0615, 0173-0874, 0173-0888, 0173-0876Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteNASAL, RESPIRATORY (INHALATION)Active IngredientsFLUTICASONE FUROATERXCUI 1797890, 1869712, 1547658, 1547660, 1547663, 1547664, 1547666, 1547668, 1547671, ... spl_id fccd0a10-9c26-42a5-b088-f4a0ac1ed1e7, 321aa12b-16e3-4458-b144-b2ce1420f188, c1e9 ... spl_set_id 893234b5-be82-4425-b850-2b884637b18e, 107100af-7ca2-44e8-b067-c0ab0a19a6dc, 50f1 ... Package NDC 0135-0616-01, 0135-0615-01, 0135-0615-02, 0135-0615-03, 0135-0615-04, 0135-0615- ... UNIIJS86977WNV

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duplicatesourceAVENTISduplicatenumbUS-SA-2014SA036256

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use