Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10881701transmissiondateformat102transmissiondate21/07/2015reporttype1serious1seriousnesshospitalization1receivedateformat102Date Received26/02/2015receiptdateformat102Date Last Updated26/02/2015fulfillexpeditecriteria2

Primary Source

reportercountryCOUNTRY NOT SPECIFIED

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age40Unit of Onset AgeyearsWeight62.87SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionAnxiety

2)

reactionmeddraversionpt18.0ReactionDepression

3)

reactionmeddraversionpt18.0ReactionIncorrect dose administered

4)

reactionmeddraversionpt18.0ReactionCellulitis

Drug

1)

drugcharacterization2medicinalproductCYMBALTA

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

2)

drugcharacterization2medicinalproductMAGNESIUM

activesubstance

activesubstancenameMAGNESIUM

openFDA Info on Medication

Brand NameMAGNESIUM METALLICUMGeneric NameMAGNESIUMManufacturersWashington Homeopathic Productsproduct_ndc68428-981Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMAGNESIUMspl_idf66824cf-f8b0-4a71-b798-821343c5a77bspl_set_id458aa1da-e975-4e11-a0c0-5ce352046ae1Package NDC68428-981-03, 68428-981-05, 68428-981-11, 68428-981-12, 68428-981-06UNIII38ZP9992A

3)

drugcharacterization2medicinalproductNYSTATIN.

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

4)

drugcharacterization2medicinalproductSUMATRIPTAN.

activesubstance

activesubstancenameSUMATRIPTAN

openFDA Info on Medication

Application Number NDA020080, ANDA213998, ANDA200183, ANDA213465, ANDA202758, NDA020132, ANDA208967 ... Brand NameIMITREX, SUMATRIPTAN, ZEMBRACE SYMTOUCH, TOSYMRAGeneric NameSUMATRIPTAN, SUMATRIPTAN SUCCINATEManufacturers GlaxoSmithKline LLC, Somerset Therapeutics, LLC, West-Ward Pharmaceuticals Corp, ... product_ndc 0173-0478, 0173-0739, 0173-0479, 70069-804, 0143-9638, 66993-083, 66993-084, 458 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUS, NASAL, ORALActive IngredientsSUMATRIPTAN SUCCINATE, SUMATRIPTANRXCUI 758523, 860088, 1657160, 1657173, 313165, 313159, 314227, 208450, 209169, 284460 ... spl_id ae0a5f62-ace2-491d-bcb4-49c28bf1e0f1, 53c62307-bd19-4418-b1b0-c0274b5595df, 7987 ... spl_set_id fee7d073-0b99-48f2-7985-0d8cf970894b, 53c62307-bd19-4418-b1b0-c0274b5595df, 2b41 ... Package NDC 0173-0739-00, 0173-0739-02, 0173-0479-00, 0173-0478-00, 70069-804-05, 70069-804- ... UNIIJ8BDZ68989, 8R78F6L9VONUIN0000175763, N0000175764, N0000175765Mechanism of ActionSerotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA]Established Pharmacologic ClassSerotonin-1b and Serotonin-1d Receptor Agonist [EPC]

5)

drugcharacterization2medicinalproductVITAMIN D

activesubstance

activesubstancenameCHOLECALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac ... product_ndc64380-737, 23155-809Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725, 9c09c2d2-ef29-4654-be7d-ed3b2b508f43spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36, 96da2c1e-6c5e-4df0-8166-3de53c08a701Package NDC64380-737-06, 64380-737-25, 23155-809-01NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

6)

drugcharacterization2medicinalproductVALTREX

activesubstance

activesubstancenameVALACYCLOVIR HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020487Brand NameVALTREXGeneric NameVALACYCLOVIR HYDROCHLORIDEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0565, 0173-0933Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVALACYCLOVIR HYDROCHLORIDERXCUI108780, 212448, 313564, 313565spl_idd0622c81-8c82-4c02-8a19-de3d41912d6dspl_set_idf8e0d8f8-cb73-4206-a484-88f5c4fbd719Package NDC0173-0933-08, 0173-0933-10, 0173-0933-56, 0173-0565-04, 0173-0565-10UNIIG447S0T1VC

7)

drugcharacterization2medicinalproductCATHETER 14 FR-6 ^

8)

drugcharacterization2medicinalproductEMLA

activesubstance

activesubstancenameLIDOCAINE\PRILOCAINE

9)

drugcharacterization2medicinalproductHYDROXYZINE HCL

activesubstance

activesubstancenameHYDROXYZINE HYDROCHLORIDE

openFDA Info on Medication

10)

drugcharacterization2medicinalproductLUNESTA

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

11)

drugcharacterization2medicinalproductSINGULAIR

activesubstance

activesubstancenameMONTELUKAST SODIUM

openFDA Info on Medication

Application NumberNDA020830, NDA021409, NDA020829Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersOrganon LLCproduct_ndc78206-170, 78206-171, 78206-173, 78206-172Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id679860ff-4c1d-432d-856a-90d4eea82ea0spl_set_id482dcc92-b47f-4ea6-854a-f5ac2aea7842Package NDC78206-171-01, 78206-170-01, 78206-173-01, 78206-172-01, 78206-172-02UNIIU1O3J18SFL

12)

drugcharacterization1medicinalproductALEMTUZUMABdrugbatchnumb1300305drugstructuredosagenumb10drugadministrationroute042drugindicationMULTIPLE SCLEROSISdrugstartdateformat102drugstartdate27/01/2014drugenddateformat610drugenddate/01/2014

activesubstance

activesubstancenameALEMTUZUMAB

openFDA Info on Medication

Application NumberBLA103948Brand NameCAMPATH, LEMTRADAGeneric NameALEMTUZUMABManufacturersGenzyme Corporationproduct_ndc58468-0357, 58468-0200Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsALEMTUZUMABRXCUI828265, 828267, 1594658, 1594663spl_id9241f842-10ad-4797-9f63-3334095abdb7, 0d382c46-0f81-4613-a0e3-0a141ee452faspl_set_id4f5f7255-7abc-4328-bd1a-ceaf139ef3e0, 6236b0bc-82e9-4447-9a78-f57d94770269Package NDC58468-0357-1, 58468-0357-3, 58468-0200-1NUIN0000175079, N0000175659Mechanism of ActionCD52-directed Antibody Interactions [MoA]Established Pharmacologic ClassCD52-directed Cytolytic Antibody [EPC]UNII3A189DH42V

13)

drugcharacterization2medicinalproductDIAZEPAM.

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application Number ANDA072079, NDA020124, ANDA210363, NDA020648, NDA211635, NDA013263, ANDA071583, ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Meridian Medical Technologies LLC, Dash Pharmaceuticals LLC, Baus ... product_ndc 0409-1273, 11704-600, 69339-136, 66490-650, 68682-650, 68682-652, 68682-655, 722 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, RECTAL, NASAL, ORALActive IngredientsDIAZEPAMRXCUI 1807459, 1807452, 2120550, 801957, 801958, 801961, 801966, 2272613, 2272619, 227 ... spl_id 14233fc1-606a-4e78-8da4-df9eedb1c793, 512dee3e-2c4c-4436-b92b-67113989cca5, 5b08 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, fa352464-14c8-49e9-b8b7-5a968b1cfa93, 6b8d ... Package NDC 0409-1273-03, 0409-1273-32, 11704-600-01, 69339-136-02, 69339-136-32, 69339-136- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

14)

drugcharacterization2medicinalproductMELATONIN

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

15)

drugcharacterization2medicinalproductRIZANIDINE

16)

drugcharacterization2medicinalproductZOFRAN ODT

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

17)

drugcharacterization2medicinalproductZONISAMIDE.

activesubstance

activesubstancenameZONISAMIDE

openFDA Info on Medication

Application Number ANDA077645, NDA020789, ANDA077625, ANDA077634, ANDA077869, ANDA214492, ANDA07765 ... Brand NameZONISAMIDE, ZONEGRANGeneric NameZONISAMIDEManufacturers Aurobindo Pharma Limited, Concordia Pharmaceuticals Inc., Cadila Healthcare Limi ... product_ndc 59651-378, 59651-379, 59651-380, 59212-680, 59212-681, 70771-1142, 70771-1143, 7 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZONISAMIDERXCUI314285, 403966, 403967, 284408, 404725spl_id 2de9e3a1-2be7-4e6d-9f0e-2a43cbb37dcd, 7de9d196-dab7-49de-955c-e944bfddb20a, 73e0 ... spl_set_id ab0631ca-5339-4570-bc27-f1dd92de1d6f, d12de43e-3ac3-4335-bc85-70d7366a91eb, 4a4d ... Package NDC 59651-378-03, 59651-378-60, 59651-378-01, 59651-378-05, 59651-379-03, 59651-379- ... NUIN0000175753, N0000008486, M0020790, N0000000235, N0000185503Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Chemical StructureSulfonamides [CS]Mechanism of ActionCarbonic Anhydrase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]UNII459384H98V

18)

drugcharacterization2medicinalproductGABAPENTIN.

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 59afc809-201f-4cf8-95f6-67ae52c0a327, 4553 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

19)

drugcharacterization2medicinalproductPROMETHAZINE

activesubstance

activesubstancenamePROMETHAZINE\PROMETHAZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040882Brand NamePROMETHAZINE HYDROCHLORIDEGeneric NamePROMETHAZINEManufacturersAmneal Pharmaceuticals LLCproduct_ndc65162-678Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPROMETHAZINE HYDROCHLORIDERXCUI992432spl_id43553934-cb17-455f-bb9a-3f44b9da0cbbspl_set_idafb16e94-03bf-4ea2-b2fe-e65f274e55a9Package NDC65162-678-86, 65162-678-90UNIIR61ZEH7I1I

20)

drugcharacterization2medicinalproductVITAMIN B COMPLEX 13-FOLIC ACID-VIT C-BIOTIN

21)

drugcharacterization2medicinalproductFLUCONAZOLE.

activesubstance

activesubstancenameFLUCONAZOLE

openFDA Info on Medication

Application Number ANDA208963, ANDA076658, ANDA076957, ANDA077731, ANDA077253, ANDA076766, ANDA0767 ... Brand NameFLUCONAZOLE, DIFLUCANGeneric NameFLUCONAZOLEManufacturers Cadila Healthcare Limited, Dr. Reddy's Laboratories Limited, Rising Pharmaceutic ... product_ndc 70771-1063, 70771-1064, 70771-1065, 70771-1066, 55111-143, 55111-144, 55111-145, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsFLUCONAZOLERXCUI 197698, 197699, 197700, 197701, 1721314, 1721315, 310352, 310353, 201900, 201901 ... spl_id 671a4cc4-0b0f-4d27-b472-482f9901656a, 54d57030-5a06-e3d5-ea3e-902dc0b19cf9, c626 ... spl_set_id 0adb2f88-8a6f-4f33-9e2d-73f537e05313, d7fa1d79-4cd3-4a55-b74b-b31e82e616a3, 4f97 ... Package NDC 70771-1063-3, 70771-1063-1, 70771-1063-5, 70771-1063-4, 70771-1064-3, 70771-1064 ... NUIN0000175487, M0002083, N0000182140, N0000182141, N0000185504Established Pharmacologic ClassAzole Antifungal [EPC]Chemical StructureAzoles [CS]Mechanism of Action Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Cyt ... UNII8VZV102JFY

22)

drugcharacterization2medicinalproductLASIX

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

23)

drugcharacterization2medicinalproductMETOCLOPRAMIDE.

activesubstance

activesubstancenameMETOCLOPRAMIDE

openFDA Info on Medication

Application Number ANDA073135, ANDA073118, ANDA204756, ANDA091392, ANDA070184, ANDA072801, ANDA0705 ... Brand NameMETOCLOPRAMIDEGeneric NameMETOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDEManufacturers Teva Parenteral Medicines, Inc., Hospira, Inc., Heritage Pharma Labs Inc. d/b/a ... product_ndc 0703-4502, 0409-3414, 23155-240, 76045-101, 76045-213, 0093-2203, 0093-2204, 498 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsMETOCLOPRAMIDE HYDROCHLORIDERXCUI311670, 727619, 311666, 311668, 104884spl_id aafe4161-f146-419c-a047-ceeeea123934, d693380f-94fa-46df-ad37-4ecf3c59b8b8, 9166 ... spl_set_id cccf04bd-7463-40b8-a41f-cb1093c358d7, 373ba08b-33ad-49fc-28a7-928e89a65314, 50a3 ... Package NDC 0703-4502-01, 0703-4502-04, 0409-3414-18, 0409-3414-01, 23155-240-32, 23155-240- ... UNIIW1792A2RVD

24)

drugcharacterization2medicinalproductMULTIVITAMIN TABLET

25)

drugcharacterization1medicinalproductSOLU-MEDROLdrugbatchnumb14001372drugstructuredosagenumb10drugadministrationroute042drugstartdateformat610drugstartdate/12/2014drugenddateformat102drugenddate11/12/2014

activesubstance

activesubstancenameMETHYLPREDNISOLONE SODIUM SUCCINATE

openFDA Info on Medication

Application NumberNDA011856Brand NameSOLU-MEDROLGeneric NameMETHYLPREDNISOLONE SODIUM SUCCINATEManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0047, 0009-0758, 0009-0698, 0009-0796, 0009-0039, 0009-0003, 0009-0018, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHYLPREDNISOLONE SODIUM SUCCINATERXCUI 207191, 207193, 311659, 314099, 1357886, 1357888, 1743704, 1743707, 1743720, 174 ... spl_id289fe43b-bdde-422c-ac63-65795a6af311, 411c816c-a44b-4366-bfb1-b89fd9c6cbddspl_set_idcd99be87-c8d9-48d6-a8e5-e081052e3f19, 7271310c-7764-4812-aa30-a5e90987c7a9Package NDC 0009-0758-01, 0009-0698-01, 0009-0796-01, 0009-0039-30, 0009-0039-28, 0009-0039- ... UNIILEC9GKY20K

26)

drugcharacterization2medicinalproductALEMTUZUMAB

activesubstance

activesubstancenameALEMTUZUMAB

openFDA Info on Medication

Application NumberBLA103948Brand NameCAMPATH, LEMTRADAGeneric NameALEMTUZUMABManufacturersGenzyme Corporationproduct_ndc58468-0357, 58468-0200Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsALEMTUZUMABRXCUI828265, 828267, 1594658, 1594663spl_id9241f842-10ad-4797-9f63-3334095abdb7, 0d382c46-0f81-4613-a0e3-0a141ee452faspl_set_id4f5f7255-7abc-4328-bd1a-ceaf139ef3e0, 6236b0bc-82e9-4447-9a78-f57d94770269Package NDC58468-0357-1, 58468-0357-3, 58468-0200-1NUIN0000175079, N0000175659Mechanism of ActionCD52-directed Antibody Interactions [MoA]Established Pharmacologic ClassCD52-directed Cytolytic Antibody [EPC]UNII3A189DH42V

27)

drugcharacterization2medicinalproductMETHYLPHENIDATE

activesubstance

activesubstancenameMETHYLPHENIDATE

openFDA Info on Medication

Application NumberNDA205489, ANDA207485, NDA021284, NDA021514Brand NameCOTEMPLA XR-ODT, METHYLPHENIDATE, DAYTRANAGeneric NameMETHYLPHENIDATE, METHYLPHENIDATE HYDROCHLORIDEManufacturers Neos Therapeutics Brands, LLC, KVK-Tech, Inc., Sandoz Inc, Noven Therapeutics, L ... product_ndc 70165-100, 70165-200, 70165-300, 10702-163, 10702-164, 0781-2361, 0781-2362, 078 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, TRANSDERMALActive IngredientsMETHYLPHENIDATE, METHYLPHENIDATE HYDROCHLORIDERXCUI 1926840, 1926847, 1926849, 1926851, 1926853, 1926855, 1091133, 1091341, 1806177, ... spl_id c6164385-573a-3b97-e053-2995a90a2b7e, 7d648f58-e026-2056-e053-2991aa0af885, d6f0 ... spl_set_id 33f70f58-c871-42c8-8adb-345caeafefcd, 2cf1b26b-199d-4c7f-ab64-4805a9def2cc, 1f89 ... Package NDC 70165-100-30, 70165-200-30, 70165-300-30, 10702-163-50, 10702-164-50, 0781-2362- ... NUIN0000175739, N0000175729Established Pharmacologic ClassCentral Nervous System Stimulant [EPC]Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE]UNII207ZZ9QZ49, 4B3SC438HI

28)

drugcharacterization2medicinalproductOXYCODONE, ACETAMINOPHEN

29)

drugcharacterization2medicinalproductBUSPIRONE

activesubstance

activesubstancenameBUSPIRONE HYDROCHLORIDE

summary

narrativeincludeclinicalCASE EVENT DATE: 20150211