Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11031598primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate17/04/2019reporttype1serious2receivedateformat102Date Received15/04/2015receiptdateformat102Date Last Updated22/02/2019fulfillexpeditecriteria2companynumbUS-SA-2014SA071424duplicate1

Report Duplicate

duplicatesourceSANOFI AVENTISduplicatenumbUS-SA-2014SA071424

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age69Unit of Onset Ageyearspatientagegroup6SexFemale

Reaction

1)

reactionmeddraversionpt21.1ReactionDrug hypersensitivityOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductQUINAPRIL HYDROCHLORIDE.drugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameQUINAPRIL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA019885, ANDA202725Brand NameACCUPRIL, QUINAPRILGeneric NameQUINAPRIL HYDROCHLORIDEManufacturersParke-Davis Div of Pfizer Inc, Aurobindo Pharma Limitedproduct_ndc 0071-0527, 0071-0530, 0071-0532, 0071-0535, 0071-1205, 0071-1410, 0071-1620, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUINAPRIL HYDROCHLORIDERXCUI207891, 207892, 207893, 207895, 312748, 312749, 312750, 314203spl_id44db5578-5817-49f8-bc11-88f018bcbb6c, 9e66076b-c857-482e-a1d3-ddc40c5171e9spl_set_id63cf5651-d52c-4d27-9fd4-ed9cd9724dff, 93e6e668-5306-4f26-81d8-cbc3a7a5e787Package NDC 0071-0527-23, 0071-0530-23, 0071-0530-40, 0071-0532-23, 0071-0532-40, 0071-0535- ... UNII33067B3N2M

2)

drugcharacterization1medicinalproductCROMOGLICATE SODIUMdrugdosagetextUNK UNK,UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameCROMOLYN SODIUM

3)

drugcharacterization1medicinalproductBETAMETHASONE.drugdosagetextUNK UNK,UNKdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameBETAMETHASONE

4)

drugcharacterization1medicinalproductGALANTAMINE HYDROBROMIDE.drugdosagetextUNK UNK,UNKdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameGALANTAMINE HYDROBROMIDE

openFDA Info on Medication

Application NumberNDA021615, ANDA078185, ANDA090178Brand NameGALANTAMINE HYDROBROMIDE, RAZADYNEGeneric NameGALANTAMINE HYDROBROMIDEManufacturers Patriot Pharmaceuticals, LLC, Janssen Pharmaceuticals, Inc., West-Ward Pharmaceu ... product_ndc 10147-0891, 10147-0881, 10147-0882, 10147-0883, 10147-0892, 10147-0893, 50458-38 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGALANTAMINE HYDROBROMIDERXCUI 310436, 310437, 579148, 860695, 860707, 860715, 602734, 602736, 602737, 860697, ... spl_id 20894f71-d4f5-42ea-9033-5e63d507cae8, ab2b6dfa-8107-11eb-8513-17f1fb2ca371, 4d32 ... spl_set_id 3bea9961-4d8a-4cf3-8b63-49af2b1fbb5b, ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc, d5b0 ... Package NDC 10147-0881-6, 10147-0882-6, 10147-0883-6, 10147-0891-3, 10147-0892-3, 10147-0893 ... UNIIMJ4PTD2VVW

5)

drugcharacterization1medicinalproductCODEINE SALT NOT SPECIFIEDdrugdosagetextUNK UNK,UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameCODEINE

6)

drugcharacterization1medicinalproductSINEQUANdrugdosagetextUNK UNK,UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameDOXEPIN HYDROCHLORIDE

7)

drugcharacterization1medicinalproductCARBOCAINEdrugdosagetextUNK UNK,UNKdrugdosageformSOLUTION FOR INJECTIONdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameMEPIVACAINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA012250, ANDA088387Brand NameCARBOCAINEGeneric NameMEPIVACAINE HYDROCHLORIDEManufacturersHospira, Inc., Septodont, Inc.product_ndc0409-1038, 0409-1036, 0409-1041, 0409-1067, 0409-2047, 0362-0753Product TypeHUMAN PRESCRIPTION DRUGRouteINFILTRATION, SUBCUTANEOUSActive IngredientsMEPIVACAINE HYDROCHLORIDERXCUI 1012722, 1012724, 1012731, 1012733, 1012737, 1012739, 1866503, 1866505, 1866524, ... spl_id7f7212c4-eb00-433b-b068-12d8cd9952ab, baf6b0d1-e57c-40a0-9162-7b861e915759spl_set_id6255ce29-25db-4964-309d-10939a436ff4, 1f2f9e40-e437-4124-97b7-df67dbafd154Package NDC 0409-1036-30, 0409-1041-30, 0409-1067-20, 0409-2047-50, 0409-1038-50, 0362-0753- ... UNII4VFX2L7EM5

8)

drugcharacterization1medicinalproductNEMBUTAL SODIUMdrugdosagetextUNK UNK,UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenamePENTOBARBITAL SODIUM

openFDA Info on Medication

Application NumberANDA083246Brand NameNEMBUTAL SODIUMGeneric NamePENTOBARBITAL SODIUMManufacturersAkronproduct_ndc76478-501Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsPENTOBARBITAL SODIUMRXCUI207468, 238090spl_ide4e54887-56cd-439f-9bb1-a098dfb6f2bcspl_set_id5c380ab0-4386-48b6-80ab-ca594b23bc74Package NDC76478-501-20, 76478-501-50UNIINJJ0475N0S

9)

drugcharacterization1medicinalproductSULARdrugdosagetextUNK UNK,UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameNISOLDIPINE

openFDA Info on Medication

Application NumberNDA020356Brand NameSULARGeneric NameNISOLDIPINEManufacturersCovis Pharma US, Incproduct_ndc70515-500, 70515-501, 70515-503Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNISOLDIPINERXCUI763519, 763521, 763589, 763591, 790489, 790840spl_id8f5e1a3c-ee01-42ad-9c36-e6b467257570spl_set_id589157fa-d129-4de3-be3d-e0e1c22c5873Package NDC70515-500-10, 70515-501-10, 70515-503-10NUIN0000175421, M0006414, N0000000069, N0000178477Established Pharmacologic ClassDihydropyridine Calcium Channel Blocker [EPC]Chemical StructureDihydropyridines [CS]Mechanism of ActionCalcium Channel Antagonists [MoA]Physiologic/Pharmacodynamic EffectDecreased Blood Pressure [PE]UNII4I8HAB65SZ

10)

drugcharacterization1medicinalproductNEDOCROMIL SODIUM.drugdosagetextUNK UNK,UNKdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameNEDOCROMIL SODIUM

openFDA Info on Medication

Application NumberNDA021009Brand NameALOCRILGeneric NameNEDOCROMIL SODIUMManufacturersAllergan, Inc.product_ndc0023-8842Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMICActive IngredientsNEDOCROMIL SODIUMRXCUI897292, 897294spl_ide1e9338a-0790-498b-af74-6404c50a7462spl_set_id2fe8d7ad-2158-4169-94b0-719ad20242b7Package NDC0023-8842-05UNIIET8IF4KS1T

11)

drugcharacterization1medicinalproductLORATADINE/PSEUDOEPHEDRINE SULFATEdrugdosagetextUNK UNK,UNKdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameLORATADINE\PSEUDOEPHEDRINE SULFATE

12)

drugcharacterization1medicinalproductDIAZEPAM.drugdosagetextUNK UNK,UNKdrugadministrationroute065actiondrug5drugadditional3

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

13)

drugcharacterization1medicinalproductQUININE SULFATE.drugdosagetextUNKactiondrug5drugadditional3

activesubstance

activesubstancenameQUININE SULFATE

openFDA Info on Medication

Application NumberNDA021799, ANDA091661, ANDA203112, ANDA203729, ANDA204372Brand NameQUININE SULFATE, CHININUM SULPHURICUM, QUALAQUINGeneric NameQUININE SULFATE, QUININEManufacturers Sun Pharmaceutical Industries, Inc., Teva Pharmaceuticals USA, Inc., Boiron, Lup ... product_ndc 53489-700, 0093-3002, 0220-1310, 49708-153, 0220-1314, 68180-560, 62106-5706, 68 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsQUININE SULFATERXCUI997010, 997012spl_id d18ebeb2-8589-423b-8c0d-4b6a11b64443, b87c29c4-4dd9-4095-85a5-af8833ae2b4f, 8529 ... spl_set_id 0b5bbefd-5b56-46f9-84f5-1456371577fd, e782283e-2608-4fd6-a8b2-6c30b9d5d3b0, 8529 ... Package NDC 53489-700-07, 53489-700-01, 0093-3002-56, 0220-1310-41, 49708-153-07, 0220-1314- ... UNIIKF7Z0E0Q2B

14)

drugcharacterization1medicinalproductDEMEROLdrugauthorizationnumb005010drugdosagetextUNK UNK,UNKdrugdosageformSOLUTION FOR INJECTIONdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameMEPERIDINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021171, NDA005010Brand NameDEMEROLGeneric NameMEPERIDINE HYDROCHLORIDEManufacturersHospira, Inc., Validus Pharmaceuticals LLCproduct_ndc 0409-1176, 0409-1178, 0409-1179, 0409-1180, 0409-1181, 0409-1201, 0409-1362, 040 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ORALActive IngredientsMEPERIDINE HYDROCHLORIDEspl_ida2ee3fbb-43db-474a-9963-f1f7b4545ed9, 8b04c129-63c0-422c-88a7-265d1fb6d579spl_set_idb31d1308-28c3-43f4-e0a6-2f3ed76b8975, 5cb2674c-a70d-4022-9188-3f711cccff5ePackage NDC 0409-1176-03, 0409-1176-30, 0409-1178-03, 0409-1178-30, 0409-1179-03, 0409-1179- ... UNIIN8E7F7Q170RXCUI861455, 861467, 861517, 861525

15)

drugcharacterization1medicinalproductHYDROMORPHONE HYDROCHLORIDE.drugdosagetextUNK UNK,UNKdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameHYDROMORPHONE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA202159, ANDA076855, ANDA212133, ANDA205629, ANDA205814, NDA019034, ANDA07747 ... Brand NameHYDROMORPHONE HYDROCHLORIDE, DILAUDIDGeneric NameHYDROMORPHONE HYDROCHLORIDEManufacturers Hikma Pharmaceuticals USA Inc., SpecGx LLC, Camber Pharmaceuticals, Inc., Trigen ... product_ndc 0641-6151, 0406-3243, 0406-3244, 0406-3249, 31722-119, 31722-120, 31722-121, 317 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ORAL, RECTALActive IngredientsHYDROMORPHONE HYDROCHLORIDERXCUI 1724276, 897696, 897702, 897710, 902729, 902736, 902741, 1306898, 897653, 897753 ... spl_id ab0205a1-df5f-499e-812c-01b34f4b4aea, 327d0a1a-4bac-4976-9ab4-7282d57cac90, 7977 ... spl_set_id 67e79859-4efc-4ea7-8211-cadf746bc864, 4c5c1cc8-c42b-46e3-ad68-8e22f57101f2, c33e ... Package NDC 0641-6151-01, 0641-6151-25, 0406-3243-01, 0406-3244-01, 0406-3249-01, 31722-119- ... UNIIL960UP2KRW

16)

drugcharacterization1medicinalproductCHLORPROMAZINE HYDROCHLORIDE.drugdosagetextUNK UNK,UNKdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameCHLORPROMAZINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA211816, ANDA213368, ANDA209755, ANDA083386, ANDA084115, ANDA212144, ANDA2145 ... Brand NameCHLORPROMAZINE HYDROCHLORIDEGeneric NameCHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINEManufacturers AuroMedics Pharma LLC, Cadila Healthcare Limited, Amneal Pharmaceuticals NY LLC, ... product_ndc 55150-318, 55150-319, 70771-1506, 70771-1507, 70771-1508, 70771-1509, 70771-1510 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, ORALActive IngredientsCHLORPROMAZINE HYDROCHLORIDERXCUI1730076, 1730078, 991039, 991044, 991188, 991194, 991336, 991053, 991332spl_id 844179d7-bfa8-47d7-a303-8118c0faad73, eabab1eb-7599-498d-b05a-fff0ea86fcef, a9e0 ... spl_set_id 07e6144a-b460-4887-b8e2-dd371c14a55c, 0ea5e0c6-0062-4be3-96f2-62397da3e77d, aa08 ... Package NDC 55150-318-01, 55150-318-25, 55150-319-01, 55150-319-25, 70771-1506-1, 70771-1506 ... UNII9WP59609J6

17)

drugcharacterization1medicinalproductTRIMETHOBENZAMIDE HYDROCHLORIDE.drugdosagetextUNK UNK, UNKdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameTRIMETHOBENZAMIDE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA076546, NDA017530, ANDA076570Brand NameTRIMETHOBENZAMIDE HYDROCHLORIDE, TIGANGeneric NameTRIMETHOBENZAMIDE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals,Inc., Par Pharmaceutical, Inc., Sun Pharmaceutical Industr ... product_ndc43386-660, 42023-119, 42023-118, 53489-376Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULARActive IngredientsTRIMETHOBENZAMIDE HYDROCHLORIDERXCUI860771, 860749, 860751, 1726680, 1726682spl_id 465b720e-d68d-4903-ad9c-1174af923f41, 9c9f34d9-8879-4f6c-a106-427b7f10c085, 90cb ... spl_set_id c18073be-d52a-4347-a8d1-6be11bcb7824, 7da90678-b229-4ad6-9193-2b8a3e9ba695, 588e ... Package NDC 43386-660-24, 43386-660-26, 43386-660-03, 42023-118-01, 42023-119-25, 53489-376- ... UNIIWDQ5P1SX7Q

18)

drugcharacterization1medicinalproductDICLOFENAC SODIUM.drugdosagetextUNKdrugdosageformSOLUTION FOR INJECTIONactiondrug5drugadditional3

activesubstance

activesubstancenameDICLOFENAC SODIUM

openFDA Info on Medication

Application Number ANDA207714, ANDA203818, ANDA204306, ANDA202769, ANDA204132, ANDA211253, ANDA2109 ... Brand Name DICLOFENAC SODIUM, ARTHRITIS PAIN RELIEVER, ASPERCREME ARTHRITIS, GOOD NEIGHBOR ... Generic Name DICLOFENAC SODIUM, DICLOFENAC, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC SOD ... Manufacturers Apotex Corp., IPG PHARMACEUTICALS, INC., Mylan Pharmaceuticals Inc., Teligent Ph ... product_ndc 60505-0406, 71085-002, 0378-8750, 52565-002, 68180-538, 56062-878, 21922-044, 41 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteTOPICAL, TRANSDERMAL, ORAL, OPHTHALMICActive IngredientsDICLOFENAC SODIUMRXCUI 1487074, 857700, 855633, 855642, 1487076, 855906, 855926, 855635, 854801, 855664 ... spl_id 9f1f3e0b-3b2f-1531-6af1-16e187c4e2c1, aa6f3401-4aad-43cc-9e01-12ffaf89a0ac, c936 ... spl_set_id 9f416595-60b2-c921-5df4-a09d5f6abe71, f491253d-14ab-4063-b57f-eb9254c1d833, 5855 ... Package NDC 60505-0406-3, 71085-002-05, 0378-8750-06, 52565-002-05, 52565-002-59, 68180-538- ... UNIIQTG126297Q

19)

drugcharacterization1medicinalproductFELODIPINE.drugdosagetextUNK UNK,UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameFELODIPINE

openFDA Info on Medication

Application Number ANDA091484, ANDA090365, ANDA075896, ANDA200815, ANDA210847, ANDA201964, ANDA2048 ... Brand NameFELODIPINEGeneric NameFELODIPINE, FELODIPINE EXTENDED-RELEASE TABLETSManufacturers Wockhardt USA LLC., Glenmark Pharmaceuticals Inc., USA, Sun Pharmaceutical Indus ... product_ndc 64679-411, 64679-412, 64679-414, 68462-233, 68462-234, 68462-235, 53489-368, 534 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFELODIPINERXCUI402695, 402696, 402698spl_id 8e372057-db1b-4820-9721-8b7b9175dda3, 6fe9a510-0582-4372-a70e-fdf3fc23dfff, 6b87 ... spl_set_id aac77fa1-04ad-497e-bbed-a21f538064c3, 2e4298cf-02e9-49c7-9803-887161e1989a, 777d ... Package NDC 64679-411-01, 64679-411-02, 64679-411-04, 64679-411-03, 64679-412-01, 64679-412- ... NUIN0000000069, N0000175421, M0006414Mechanism of ActionCalcium Channel Antagonists [MoA]Established Pharmacologic ClassDihydropyridine Calcium Channel Blocker [EPC]Chemical StructureDihydropyridines [CS]UNIIOL961R6O2C

20)

drugcharacterization1medicinalproductQUININE (SALT NOT SPECIFIED)drugdosagetextUNK UNK,UNKdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameQUININE

21)

drugcharacterization1medicinalproductPERCODAN [ACETYLSALICYLIC ACID;CAFFEINE;HOMATROPINE TEREPHTHALATE;OXYCdrugdosagetextUNK UNK,UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameASPIRIN\OXYCODONE HYDROCHLORIDE\OXYCODONE TEREPHTHALATE

22)

drugcharacterization1medicinalproductNABUMETONE.drugdosagetextUNKactiondrug5drugadditional3

activesubstance

activesubstancenameNABUMETONE

openFDA Info on Medication

Application Number ANDA091083, ANDA075280, ANDA203166, ANDA090445, ANDA078671, ANDA078420, ANDA0751 ... Brand Name NABUMETONE, RELAFEN DS, NABUMETONE 500 MG, NABUMETONE 750 MG, NABUMETONE 1000 MG ... Generic NameNABUMETONE, NABUMENTONEManufacturers Actavis Pharma, Inc., Eon Labs, Inc., Carwin Pharmaceutical Associates, LLC, Lup ... product_ndc 0591-3670, 0591-3671, 0185-0145, 0185-0146, 15370-170, 68180-141, 68180-142, 797 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNABUMETONERXCUI311892, 311893, 427726, 2200291, 206958, 206959spl_id a3ef9a9d-9681-4d58-8d94-84826e6def03, ea45619f-82b6-46d6-bcea-ac43bbe44613, 3051 ... spl_set_id 53656d70-6572-4669-6465-6c6973555341, e21f89cf-ec07-4b07-9c9b-796b0111df39, a9a0 ... Package NDC 0591-3670-01, 0591-3670-05, 0591-3671-01, 0591-3671-05, 0185-0145-01, 0185-0145- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIILW0TIW155Z

23)

drugcharacterization1medicinalproductDICLOFENAC SODIUM.drugdosagetextUNK UNK,UNKdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameDICLOFENAC SODIUM

openFDA Info on Medication

Application Number ANDA207714, ANDA203818, ANDA204306, ANDA202769, ANDA204132, ANDA211253, ANDA2109 ... Brand Name DICLOFENAC SODIUM, ARTHRITIS PAIN RELIEVER, ASPERCREME ARTHRITIS, GOOD NEIGHBOR ... Generic Name DICLOFENAC SODIUM, DICLOFENAC, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC SOD ... Manufacturers Apotex Corp., IPG PHARMACEUTICALS, INC., Mylan Pharmaceuticals Inc., Teligent Ph ... product_ndc 60505-0406, 71085-002, 0378-8750, 52565-002, 68180-538, 56062-878, 21922-044, 41 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteTOPICAL, TRANSDERMAL, ORAL, OPHTHALMICActive IngredientsDICLOFENAC SODIUMRXCUI 1487074, 857700, 855633, 855642, 1487076, 855906, 855926, 855635, 854801, 855664 ... spl_id 9f1f3e0b-3b2f-1531-6af1-16e187c4e2c1, aa6f3401-4aad-43cc-9e01-12ffaf89a0ac, c936 ... spl_set_id 9f416595-60b2-c921-5df4-a09d5f6abe71, f491253d-14ab-4063-b57f-eb9254c1d833, 5855 ... Package NDC 60505-0406-3, 71085-002-05, 0378-8750-06, 52565-002-05, 52565-002-59, 68180-538- ... UNIIQTG126297Q

24)

drugcharacterization1medicinalproductDARBIDdrugdosagetextUNK UNK,UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameISOPROPAMIDE IODIDE

25)

drugcharacterization1medicinalproductBUPROPION HYDROCHLORIDE.drugdosagetextUNK UNK,UNKdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameBUPROPION HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA075932, ANDA211020, ANDA203650, ANDA208652, NDA022497, ANDA200216, ANDA20230 ... Brand Name BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE (XL), BUPROPION, BUPROPION HYDR ... Generic NameBUPROPION HYDROCHLORIDE, EXTENDED-RELEASEManufacturers Eon Labs, Inc., Graviti Pharmaceuticals Private Limited, Sun Pharmaceutical Indu ... product_ndc 0185-0410, 0185-0415, 0185-1111, 69844-064, 69844-065, 63304-724, 0781-5528, 078 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI 993503, 993518, 993536, 993541, 993557, 1232585, 993687, 993691, 1801289, 993545 ... spl_id 93be4c14-9bab-40e5-884b-5d3cb377210f, 5043ec33-8fc8-4cab-9c2f-a82e40f2cd6e, 338f ... spl_set_id 165475dd-a250-48bb-b4c8-65c189194a9b, f32a4532-7dfd-4aa5-bb48-afbbd2eefb7c, fddb ... Package NDC 0185-0410-60, 0185-0410-01, 0185-0410-05, 0185-0410-52, 0185-0415-05, 0185-0415- ... UNIIZG7E5POY8O

26)

drugcharacterization1medicinalproductTIZANIDINE HYDROCHLORIDE.drugdosagetextUNKactiondrug5drugadditional3

activesubstance

activesubstancenameTIZANIDINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA208622, NDA020397, NDA021447, ANDA078868, ANDA210021, ANDA213223, ANDA213544 ... Brand NameTIZANIDINE HYDROCHLORIDE, ZANAFLEXGeneric NameTIZANIDINE HYDROCHLORIDEManufacturers Cadila Healthcare Limited, Covis Pharma US, Inc, Apotex Corp., Nivagen Pharmaceu ... product_ndc 70771-1067, 70771-1068, 70771-1069, 70515-594, 70515-602, 70515-604, 70515-606, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTIZANIDINE HYDROCHLORIDE, TIZANIDINERXCUI485484, 485485, 485486, 153735, 313413, 580267, 583165, 583211, 313412spl_id ac68e443-89c9-42b1-aa4c-66a32746d81e, 4caebc2e-bf10-442a-b24d-c3b51876c67f, 80e7 ... spl_set_id 5f4889d1-1387-4c90-9b76-00beda3c1683, 043d9e51-bfa2-4add-9058-5ece332f7e99, 3dd0 ... Package NDC 70771-1067-8, 70771-1067-5, 70771-1067-4, 70771-1068-8, 70771-1068-5, 70771-1068 ... UNIIB53E3NMY5C, 6AI06C00GWNUIN0000009918, N0000175554Mechanism of ActionAdrenergic alpha2-Agonists [MoA]Established Pharmacologic ClassCentral alpha-2 Adrenergic Agonist [EPC]

27)

drugcharacterization1medicinalproductPROPRANOLOL HYDROCHLORIDE.drugdosagetextUNK UNK,UNKdrugdosageformTABLETdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenamePROPRANOLOL HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA090321, ANDA071972, ANDA071976, ANDA070979, ANDA070690, ANDA212026, ANDA0784 ... Brand Name PROPRANOLOL HYDROCHLORIDE, INDERAL LA, INNOPRAN XL, HEMANGEOL, PROPRANOLOL HYDRO ... Generic NamePROPRANOLOL HYDROCHLORIDEManufacturers Zydus Pharmaceuticals (USA) Inc., Amneal Pharmaceuticals NY LLC, West Ward Pharm ... product_ndc 68382-161, 68382-162, 68382-163, 68382-164, 69238-2077, 69238-2078, 69238-2079, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsPROPRANOLOL HYDROCHLORIDERXCUI 856460, 856481, 856535, 856569, 856448, 856457, 856519, 856556, 856578, 856724, ... spl_id c3cf9407-83ca-40fa-9794-623ee06074d0, 1222defc-0f90-4ec9-bfc0-46438d59f164, 2788 ... spl_set_id 5a7858eb-9d2d-44d9-9f81-c78ba3ce1815, 14d0c95d-418f-40a8-bad3-e20c82424960, 8fe0 ... Package NDC 68382-161-16, 68382-161-01, 68382-161-05, 68382-161-10, 68382-161-30, 68382-161- ... UNIIF8A3652H1V

28)

drugcharacterization1medicinalproductVERAPAMIL HYDROCHLORIDE.drugdosagetextUNK UNK,UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameVERAPAMIL HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA206173, ANDA211015, ANDA211035, ANDA070737, ANDA213232, NDA019614, ANDA21436 ... Brand NameVERAPAMIL HYDROCHLORIDE, CALAN SR, VERELAN, VERELAN PMGeneric NameVERAPAMIL HYDROCHLORIDEManufacturers Nivagen Pharmaceuticals, Inc., Somerset Therapeutics, LLC, Hospira, Inc., Caplin ... product_ndc 75834-158, 75834-159, 70069-271, 70069-272, 70069-273, 0409-1144, 65145-113, 651 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsVERAPAMIL HYDROCHLORIDERXCUI 897640, 897649, 1665057, 1665061, 897624, 897659, 897661, 897676, 897680, 897584 ... spl_id d03bab90-05ed-4dac-a973-06bf65e0e50d, 27763b11-2577-411f-be8c-b5e5f524abdb, 3e68 ... spl_set_id e36e485f-fbed-4e30-9a63-984931f2e54e, 50131bbc-ad43-4708-946f-e4000828137c, 7005 ... Package NDC 75834-158-01, 75834-159-01, 75834-159-05, 70069-271-01, 70069-271-05, 70069-271- ... UNIIV3888OEY5R

29)

drugcharacterization1medicinalproductNORTRIPTYLINE HYDROCHLORIDE.drugdosagetextUNK UNK,UNKdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameNORTRIPTYLINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA213441, NDA018013, ANDA073556, ANDA075520, ANDA075606, ANDA074132Brand NameNORTRIPTYLINE HYDROCHLORIDE, PAMELORGeneric NameNORTRIPTYLINE HYDROCHLORIDEManufacturers Cadila Healthcare Limited, SpecGx LLC, Mayne Pharma Inc., Zydus Pharmaceuticals ... product_ndc 70771-1612, 70771-1613, 70771-1614, 70771-1615, 0406-9910, 0406-9911, 0406-9912, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNORTRIPTYLINE HYDROCHLORIDERXCUI198045, 198046, 198047, 317136, 209329, 209339, 209350, 209391spl_id 2e1c5e82-2293-4241-87ff-df3a7398f7fc, ad133e62-40fe-496f-8bb4-575c5102e781, a780 ... spl_set_id f22dce73-b895-4fe2-8cf7-816dca93c246, e17dc299-f52d-414d-ab6e-e809bd6f8acb, 1e00 ... Package NDC 70771-1612-3, 70771-1612-1, 70771-1612-5, 70771-1613-3, 70771-1613-1, 70771-1613 ... UNII00FN6IH15D

30)

drugcharacterization1medicinalproductHYALURONIDASEdrugdosagetextUNK UNK,UNKdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameHYALURONIDASE

openFDA Info on Medication

Application NumberBLA021665Brand NameAMPHADASEGeneric NameHYALURONIDASEManufacturersAmphastar Pharmaceuticals, Inc.product_ndc0548-9090Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsHYALURONIDASERXCUI238271, 542925spl_idc8b90610-c372-4908-9861-8a628f7e0773spl_set_id8396ea96-7cb5-4e26-87a4-90bca9c3c6ddPackage NDC0548-9090-10NUIN0000175531, M0009499Established Pharmacologic ClassEndoglycosidase [EPC]Chemical StructureGlycoside Hydrolases [CS]UNII8KOG53Z5EM

31)

drugcharacterization1medicinalproductLUNESTAdrugdosagetextUNK UNK,UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

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

32)

drugcharacterization1medicinalproductPENTOTHALdrugdosagetextUNK UNK,UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameTHIOPENTAL SODIUM