Report

Version of Safety Report ID1Safety Report ID11824724primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate05/03/2016reporttype1serious1seriousnessother1receivedateformat102Date Received10/12/2015receiptdateformat102Date Last Updated10/12/2015fulfillexpeditecriteria1companynumbUS-CELGENE-USA-2015102225duplicate1

Report Duplicate

duplicatesourceCELGENEduplicatenumbUS-CELGENE-USA-2015102225

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Weight77.18SexFemale

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
- 5)
Drug
summary

Reaction

1)

reactionmeddraversionpt18.1ReactionSpider veinOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.1ReactionCardiac murmurOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.1ReactionOedema peripheralOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.1ReactionOverweightOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.1ReactionSkin infectionOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductRESTASISdrugstructuredosagenumb.05drugstructuredosageunit030drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformDROPSdrugadministrationroute047drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCYCLOSPORINE

openFDA Info on Medication

Application NumberNDA050790Brand NameRESTASISGeneric NameCYCLOSPORINEManufacturersAllergan, Inc.product_ndc0023-9163Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMICActive IngredientsCYCLOSPORINERXCUI2572292, 2572293spl_id554c342b-15e5-4910-938f-d1c38ff0e516spl_set_id8e24af2b-bc1c-4849-94f2-6df950cdca89Package NDC0023-9163-12, 0023-9163-30, 0023-9163-60NUIN0000175457, N0000175458, N0000182141, N0000185503Established Pharmacologic ClassCalcineurin Inhibitor Immunosuppressant [EPC]Mechanism of Action Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprote ... UNII83HN0GTJ6D

2)

drugcharacterization2medicinalproductDHEAdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePRASTERONE

openFDA Info on Medication

Brand NameDHEAGeneric NameDHEA (DEHYDROEPIANDROSTERONE), PRASTERONEManufacturersDeseret Biologicals, Inc., VIATREXX BIO INCORPORATEDproduct_ndc43742-0564, 63776-653Product TypeHUMAN OTC DRUGRouteORALActive IngredientsPRASTERONEspl_ida67696cb-6667-43c5-85f5-ed2d0148b170, d58fd674-e812-3332-e053-2995a90a3928spl_set_idd6edd874-495c-4eb5-bf3d-72c2ee41fc88, b1971d8f-e72d-96a0-c43f-7ba0103e921ePackage NDC43742-0564-1, 63776-653-14UNII459AG36T1B

3)

drugcharacterization1medicinalproductREVLIMIDdrugbatchnumbUNKNOWNdrugauthorizationnumb021880drugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULESdrugadministrationroute048drugindicationLEUKAEMIAdrugstartdateformat610drugstartdate/02/2010actiondrug4drugrecurreadministration3

activesubstance

activesubstancenameLENALIDOMIDE

openFDA Info on Medication

Application NumberNDA021880Brand NameREVLIMIDGeneric NameLENALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-402, 59572-405, 59572-410, 59572-415, 59572-420, 59572-425Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLENALIDOMIDERXCUI 602910, 602912, 616114, 616116, 643712, 643714, 643720, 643722, 1242231, 1242233 ... spl_idab1a612f-883f-4e2d-8015-2efb50b08783spl_set_id5fa97bf5-28a2-48f1-8955-f56012d296bePackage NDC 59572-402-28, 59572-402-00, 59572-405-28, 59572-405-00, 59572-410-28, 59572-410- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIIF0P408N6V4

4)

drugcharacterization2medicinalproductCODEINE SULFATE.drugstructuredosagenumb60drugstructuredosageunit003drugdosageformUNKNOWNdrugadministrationroute065drugindicationPAIN

activesubstance

activesubstancenameCODEINE SULFATE

openFDA Info on Medication

Application NumberANDA203046, NDA022402Brand NameCODEINE SULFATEGeneric NameCODEINE SULFATEManufacturersLannett Company, Inc., West-Ward Pharmaceuticals Corp.product_ndc0527-1698, 0527-1699, 0054-0243, 0054-0245, 0054-0244Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCODEINE SULFATERXCUI997287, 997296, 997170spl_idc4ff8bae-b0d0-4ccb-a879-ec3210e4c638, bf96e069-9d09-4c83-a843-f189e89ddd56spl_set_id5819bdf7-300e-45b8-8f3a-447b53656293, 010905f9-3bcb-4b50-9fe8-a3ad0010f14cPackage NDC 0527-1698-91, 0527-1698-01, 0527-1699-01, 0054-0243-24, 0054-0245-25, 0054-0244- ... UNII11QV9BS0CB

5)

drugcharacterization2medicinalproductDILAUDIDdrugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb6drugintervaldosagedefinition805drugdosagetext.1 PERCENTdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameHYDROMORPHONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA019034, NDA019892, NDA019891Brand NameDILAUDIDGeneric NameHYDROMORPHONE HYDROCHLORIDEManufacturersFresenius Kabi USA, LLC, Rhodes Pharmaceuticals L.P.product_ndc76045-009, 76045-010, 76045-121, 42858-122, 42858-234, 42858-338, 42858-416Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ORALActive IngredientsHYDROMORPHONE HYDROCHLORIDERXCUI 897756, 897757, 1433251, 1872265, 1872269, 1872752, 2277368, 2277370, 897657, 89 ... spl_id 91e4f1a1-03b1-4625-b4d4-19ab7667ee4c, f89754d5-a3d4-44c9-b175-1bf0581e18da, 6cac ... spl_set_id 9eebd88a-5632-460f-b7b6-26c8a180540d, 4d77772f-874f-9c87-2d80-ca467c7690a1, d6b4 ... Package NDC 76045-009-96, 76045-009-06, 76045-009-01, 76045-009-11, 76045-010-01, 76045-010- ... UNIIL960UP2KRW

6)

drugcharacterization2medicinalproductMELATONINdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMELATONIN

openFDA Info on Medication

Brand NameMELATONIN, MELATONIN PHENOLIC, MELATONIN CORD, MELATONIN 1527Generic NameMELATONINManufacturers BioActive Nutritional, Inc., Energique, Inc., Professional Complementary Health ... product_ndc43857-0086, 44911-0247, 44911-0194, 63083-1527, 43742-0771Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMELATONINspl_id e189499d-9da3-43fc-8a0b-9d5dd0923b11, 904c041a-ff84-4152-9b10-ea5d1b669d24, 0673 ... spl_set_id cd82eb5d-a44a-4512-ad65-0fffae70d1d0, 895cb8a5-33ea-4764-86a6-1da513dcd2c1, 9a59 ... Package NDC43857-0086-1, 44911-0247-1, 44911-0194-1, 63083-1527-1, 43742-0771-1UNIIJL5DK93RCL

7)

drugcharacterization1medicinalproductREVLIMIDdrugbatchnumbUNKNOWNdrugauthorizationnumb021880drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5-10 MGdrugdosageformCAPSULESdrugadministrationroute048drugindicationPLASMA CELL MYELOMAdrugstartdateformat610drugstartdate/12/2012actiondrug4drugrecurreadministration3

activesubstance

activesubstancenameLENALIDOMIDE

openFDA Info on Medication

8)

drugcharacterization2medicinalproductMORPHINE SULPHATEdrugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition805drugdosagetext480 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationBREAKTHROUGH PAIN

activesubstance

activesubstancenameMORPHINE SULFATE

9)

drugcharacterization2medicinalproductXANAXdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosagetext240 MILLIGRAM/MILLILITERSdrugdosageformUNKNOWNdrugadministrationroute065drugindicationTREMOR

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0094, 0009-0029, 0009-0055, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_idf364e489-b47b-4283-a7fe-d5b15f77447e, bf933d5a-53e2-4454-a040-cacc061bca92spl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

10)

drugcharacterization2medicinalproductLORAZEPAM.drugdosagetext4 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, LOREEV XR, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, Hikma Pharmaceuticals USA Inc., Aurol ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 2569564, 25695 ... spl_id 8b30da4f-e5a1-4e8a-9971-b5c687508d81, 4f2988b1-2854-4051-962f-07cc925608ab, 66ed ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-11, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

11)

drugcharacterization1medicinalproductREVLIMIDdrugbatchnumbUNKNOWNdrugauthorizationnumb021880drugstructuredosagenumb10drugstructuredosageunit003drugdosageformCAPSULESdrugadministrationroute048drugstartdateformat102drugstartdate19/01/2015actiondrug4drugrecurreadministration3

activesubstance

activesubstancenameLENALIDOMIDE

openFDA Info on Medication

12)

drugcharacterization2medicinalproductNYSTATIN.drugdosageformUNKNOWNdrugadministrationroute065drugindicationSKIN REACTION

activesubstance

activesubstancenameNYSTATIN

openFDA Info on Medication

Application Number ANDA203621, ANDA064142, ANDA211838, ANDA062124, ANDA208581, ANDA062838, ANDA0651 ... Brand NameNYSTATIN, NYAMYC, NYSTOPGeneric NameNYSTATIN, NYSTATIN ORAL SUSPENSION, NYSTATIN OINTMENT, NYSTATIN CREAMManufacturers Pharmaceutical Associates, Inc., VistaPharm, Inc., Torrent Pharmaceuticals Limit ... product_ndc 0121-0810, 0121-4810, 66689-037, 13668-534, 0168-0007, 70771-1585, 53489-400, 80 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, TOPICALActive IngredientsNYSTATINRXCUI312055, 884308, 646456, 312059, 584414, 543546, 261178spl_id d57cde69-0eb9-180d-e053-2995a90a33aa, 91e9fe62-a1e7-46e6-8357-cdc2a93cc62f, d61b ... spl_set_id 31e3da10-5a7b-4bc5-8a4f-3e786b64c13a, 41034d7b-33a1-4d6d-b425-9cfefff8d518, 4949 ... Package NDC 0121-0810-02, 0121-0810-16, 0121-4810-05, 0121-4810-40, 0121-4810-00, 0121-4810- ... NUIN0000175498, M0017172Established Pharmacologic ClassPolyene Antifungal [EPC]Chemical StructurePolyenes [CS]UNIIBDF1O1C72E

13)

drugcharacterization2medicinalproductZOFRANdrugstructuredosagenumb8drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUNKNOWNdrugadministrationroute065drugindicationNAUSEA

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

14)

drugcharacterization2medicinalproductLIDOCAINE.drugstructuredosagenumb5drugstructuredosageunit030drugdosageformGELdrugadministrationroute065drugindicationMUSCLE SPASMS

activesubstance

activesubstancenameLIDOCAINE

openFDA Info on Medication

Application Number ANDA208822, part348, ANDA088586, part346, ANDA040911, ANDA206297, ANDA206498, AN ... Brand Name LIDOCAINE, LIDOCAINE 4% CREAM, DR. RICHS NUMBING, FIRSTCARE PAIN RELIEF GEL PATC ... Generic Name LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, ... Manufacturers VITRUVIAS THERAPEUTICS, Teligent Pharma, Inc., GenZ Online LLC, USpharma Ltd, Sa ... product_ndc 69680-120, 52565-122, 69191-500, 71594-601, 49873-617, 50488-2004, 63323-201, 24 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRoute TOPICAL, INFILTRATION, PERINEURAL, RECTAL, PERCUTANEOUS, TRANSDERMAL, EPIDURAL, ... Active Ingredients LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE, PHENYLEPHRINE HYDROCH ... RXCUI 1543069, 1421893, 1291672, 1737778, 1010033, 1366789, 1872886, 1534792, 1442274, ... spl_id 486396b5-d925-44a9-a3ad-530fc0b69ec0, a8eeed92-d89f-4119-b862-31e1f91f6b21, 47f5 ... spl_set_id a10d6d19-a275-483d-bf64-1ead5c30745c, a3216e25-82bb-4905-ac0b-b2ef4aa32ea0, a346 ... Package NDC 69680-120-35, 52565-122-07, 52565-122-15, 52565-122-30, 69191-500-06, 71594-601- ... NUIN0000175682, M0000897, N0000175426, N0000175976Established Pharmacologic ClassAmide Local Anesthetic [EPC], Antiarrhythmic [EPC]Chemical StructureAmides [CS]Physiologic/Pharmacodynamic EffectLocal Anesthesia [PE]UNII98PI200987, V13007Z41A, F5UM2KM3W7, 04JA59TNSJ, 30Q7KI53AK

15)

drugcharacterization2medicinalproductSYNTHROIDdrugstructuredosagenumb150drugstructuredosageunit004drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_ided6f6960-2439-4bb0-bb7f-c7d05e4d37a5spl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

16)

drugcharacterization2medicinalproductCHLORIDEdrugdosagetext400 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationTOOTH DISORDER

activesubstance

activesubstancenameCHLORIDE ION

17)

drugcharacterization1medicinalproductREVLIMIDdrugbatchnumbUNKNOWNdrugauthorizationnumb021880drugstructuredosagenumb10drugstructuredosageunit003drugdosageformCAPSULESdrugadministrationroute048drugstartdateformat610drugstartdate/08/2014actiondrug4drugrecurreadministration3

activesubstance

activesubstancenameLENALIDOMIDE

openFDA Info on Medication

18)

drugcharacterization2medicinalproductDEXAMETHASONE.drugstructuredosagenumb2.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameDEXAMETHASONE

openFDA Info on Medication

Application Number NDA022315, ANDA088237, ANDA088481, NDA211379, ANDA215106, ANDA201270, ANDA088254 ... Brand Name OZURDEX, TAPERDEX 12-DAY, DEXAMETHASONE, HEMADY, DEXAMETHASONE 1.5 MG, ZCORT, TA ... Generic NameDEXAMETHASONE, DEXAMETHASONE 1.5 MGManufacturers Allergan, Inc., Xspire Pharma, Llc, Alvogen Inc., Acrotech Biopharma LLC, Fera P ... product_ndc 0023-3348, 42195-149, 42195-490, 47781-914, 47781-916, 72893-015, 48102-047, 481 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREAL, ORAL, INTRAOCULAR, OPHTHALMIC, INTRACANALICULARActive IngredientsDEXAMETHASONERXCUI 854177, 854181, 197580, 1943550, 1998481, 197582, 197583, 2261802, 2286261, 1975 ... spl_id 04b2b881-a84c-417c-ba09-8a76cf46faea, 450c31b5-c5c0-44bb-bde5-66748f67b156, 4ce5 ... spl_set_id 4b204f44-6e8a-4d17-803c-268f0b04679f, c3c59b82-1343-470d-bbc7-e40da3c0a28f, 9ab2 ... Package NDC 0023-3348-07, 0023-3348-08, 42195-149-12, 42195-490-12, 47781-914-01, 47781-914- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII7S5I7G3JQL

19)

drugcharacterization2medicinalproductADDERALLdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext16 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancename AMPHETAMINE ASPARTATE\AMPHETAMINE SULFATE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMP ...

openFDA Info on Medication

Application NumberANDA040422, NDA021303Brand NameADDERALL, ADDERALL XRGeneric Name DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, ... ManufacturersTeva Pharmaceuticals USA, Inc., Takeda Pharmaceuticals America, Inc.product_ndc 57844-105, 57844-117, 57844-110, 57844-112, 57844-115, 57844-120, 57844-130, 540 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive Ingredients AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHA ... RXCUI 541363, 541365, 541878, 541879, 541892, 541894, 577957, 577960, 577961, 577962, ... spl_id12989a25-f31c-4550-9b5d-f354f7f0af45, e3546445-6a4a-46a2-af40-026167005259spl_set_idf22635fe-821d-4cde-aa12-419f8b53db81, aff45863-ffe1-4d4f-8acf-c7081512a6c0Package NDC 57844-105-01, 57844-117-01, 57844-110-01, 57844-112-01, 57844-115-01, 57844-120- ... UNIIJJ768O327N, O1ZPV620O4, G83415V073, 6DPV8NK46S

20)

drugcharacterization1medicinalproductREVLIMIDdrugbatchnumbUNKNOWNdrugauthorizationnumb021880drugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MILLIGRAMdrugdosageformCAPSULESdrugadministrationroute048drugstartdateformat610drugstartdate/03/2014actiondrug4drugrecurreadministration3

activesubstance

activesubstancenameLENALIDOMIDE

openFDA Info on Medication

21)

drugcharacterization2medicinalproductTESTOSTERONE.drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext.3571 MILLIGRAMdrugdosageformINJECTIONdrugadministrationroute030drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameTESTOSTERONE

openFDA Info on Medication

Application Number NDA022309, ANDA205781, ANDA204268, ANDA210835, ANDA076737, ANDA208620, ANDA21230 ... Brand Name ANDROGEL, TESTOSTERONE, VOGELXO, TESTIM, ANDRODERM, FORTESTA, TESTOPEL, NATESTO ... Generic NameTESTOSTERONE, TESTOSTERONE,, TESTOSTERONE CYPIONATEManufacturers AbbVie Inc., Zydus Pharmaceuticals USA Inc, Padagis Israel Pharmaceuticals Ltd, ... product_ndc 0051-8462, 68382-362, 45802-281, 45802-754, 45802-366, 70700-112, 0591-2921, 059 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteTRANSDERMAL, TOPICAL, ORAL, SUBCUTANEOUS, NASAL, INTRAMUSCULARActive IngredientsTESTOSTERONE, TESTOSTERONE CYPIONATERXCUI 1597075, 1597076, 1597120, 1597121, 1597126, 1597127, 1596780, 1597123, 1597129, ... spl_id d34e7ee8-3f6b-4473-8e1b-f3a90467fb6c, 52cc0e06-8081-21e1-e3f6-cebcda7bc3f8, b25d ... spl_set_id 8677ba5b-8374-46cb-854c-403972e9ddf3, 13c89fbb-f8e7-1f70-ef5a-468b90efb933, 54fc ... Package NDC 0051-8462-33, 0051-8462-12, 0051-8462-31, 0051-8462-01, 0051-8462-30, 68382-362- ... NUIN0000175824, N0000000146, M0001109Established Pharmacologic ClassAndrogen [EPC]Mechanism of ActionAndrogen Receptor Agonists [MoA]Chemical StructureAndrostanes [CS]UNII3XMK78S47O, M0XW1UBI14

22)

drugcharacterization2medicinalproductESTRADIOL.drugstructuredosagenumb2drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext16 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameESTRADIOL

openFDA Info on Medication

Application Number NDA020538, NDA020655, ANDA040197, NDA020908, ANDA075182, NDA020375, ANDA205256, ... Brand Name ESTRADIOL, ALORA, ESTRACE, VAGIFEM, MENOSTAR, YUVAFEM, ESTRADIOL VAGINAL INSERTS ... Generic NameESTRADIOL, ESTRADIOL,Manufacturers Sandoz Inc, Allergan, Inc., Novo Nordisk, Mylan Pharmaceuticals Inc., Bayer Heal ... product_ndc 0781-7129, 0781-7138, 0781-7144, 0781-7156, 0781-7167, 0023-5885, 0023-5886, 002 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteTRANSDERMAL, ORAL, VAGINAL, TOPICALActive IngredientsESTRADIOL, ESTRADIOL HEMIHYDRATERXCUI 241946, 242891, 242892, 248478, 1149632, 310173, 310180, 486155, 1149645, 197657 ... spl_id 9a1c6881-b6bc-45b9-ac5c-c5912e30d921, 4ec6701d-54cd-4f8f-8449-02f43094950e, 7d28 ... spl_set_id c4da6de7-9ab1-4fcf-88f3-fe785019e6e7, ac676026-14be-486a-9d64-6702bd9e51ea, a380 ... Package NDC 0781-7129-58, 0781-7129-83, 0781-7129-40, 0781-7138-58, 0781-7138-83, 0781-7138- ... NUIM0447348, N0000175825, N0000000100Chemical StructureEstradiol Congeners [CS]Established Pharmacologic ClassEstrogen [EPC]Mechanism of ActionEstrogen Receptor Agonists [MoA]UNII4TI98Z838E, CXY7B3Q98Z

23)

drugcharacterization2medicinalproductPROGESTERONE.drugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePROGESTERONE

openFDA Info on Medication

Application Number NDA201110, ANDA075906, ANDA200900, NDA019781, ANDA207724, ANDA210965, ANDA211285 ... Brand Name FERRING PHARMACEUTICALS INC., PROGESTO-LIFE, PROGESTERONE, ADVANCED FORMULA PROG ... Generic NamePROGESTERONE, PROGESTERONE,Manufacturers Ferring Pharmaceuticals Inc., Smoky Mountain Naturals, LLC - DBA SMNutrition, Bi ... product_ndc 55566-9400, 82653-003, 43857-0120, 63323-261, 43857-0103, 69452-148, 69452-149, ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteVAGINAL, TOPICAL, ORAL, INTRAMUSCULAR, TRANSDERMALActive IngredientsPROGESTERONERXCUI 2537633, 312644, 260243, 312641, 261319, 262080, 153579, 153580, 312643, 312645, ... spl_id 4b80545a-0641-49cf-8f57-476862226a17, db874f40-222c-6cef-e053-2995a90abaab, d1fe ... spl_set_id de063435-6aa7-4711-8732-1c5d0358e98b, 321d86ca-af62-44c0-873d-3b7c0bcbac8c, cddb ... Package NDC 55566-9400-0, 55566-9400-1, 82653-003-01, 43857-0120-1, 63323-261-10, 43857-0103 ... NUIM0017672, N0000175601Chemical StructureProgesterone [CS]Established Pharmacologic ClassProgesterone [EPC]UNII4G7DS2Q64Y

24)

drugcharacterization2medicinalproductLUNESTAdrugdosagetext2 TABLETdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

25)

drugcharacterization2medicinalproductKETOCONAZOLE.drugstructuredosagenumb2drugstructuredosageunit030drugdosagetext4 MILLIGRAMdrugdosageformSHAMPOOdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameKETOCONAZOLE

openFDA Info on Medication

Application Number NDA020310, ANDA076942, ANDA210457, ANDA075581, ANDA091550, ANDA075912, ANDA07641 ... Brand NameNIZORAL, KETOCONAZOLE, KETODAN, EXTINA, XOLEGELGeneric NameKETOCONAZOLE, KETOCONAZOLE FOAM, KETOCONAZOLE CREAM, 2%Manufacturers Kramer Laboratories, THIRTY MADISON INC, Strides Shasun Limited, Teva Pharmaceut ... product_ndc 55505-192, 71713-097, 64380-827, 0093-3219, 55505-196, 45802-532, 35573-433, 458 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteTOPICAL, ORALActive IngredientsKETOCONAZOLERXCUI240812, 608844, 106336, 197853, 203088, 728550, 1300272, 729768, 647253, 664961spl_id 7afd420a-2022-4666-b027-28d9b15dfd03, f7243345-244e-4393-9ab5-b62bc0eed144, a130 ... spl_set_id 63840ff7-d447-4f4e-a05b-1fbed2da8a25, 1f5cd9f4-0db4-4062-b5ec-c33611265e02, 6d4b ... Package NDC 55505-192-40, 55505-192-33, 55505-192-57, 55505-192-59, 71713-097-04, 64380-827- ... NUIN0000175487, M0002083, N0000182141, N0000190115, N0000185503Established Pharmacologic ClassAzole Antifungal [EPC]Chemical StructureAzoles [CS]Mechanism of Action Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Gl ... UNIIR9400W927I

summary

narrativeincludeclinicalCASE EVENT DATE: 2015

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