Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10248461primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious1seriousnessother1receivedateformat102Date Received20/06/2014receiptdateformat102Date Last Updated20/06/2014fulfillexpeditecriteria1companynumbUS-AMGEN INC.-USASP2014045976duplicate1

Report Duplicate

duplicatesourceAMGENduplicatenumbUS-AMGEN INC.-USASP2014045976

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age66Unit of Onset AgeyearsWeight68.03SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionBladder prolapseOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionUrethral repairOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionPelvic discomfortOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionPainOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionSpinal disorderOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionTherapeutic response decreasedOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductENBRELdrugauthorizationnumb103795drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext50 MG, QWKdrugdosageformSolution for injection in pre-filled syringedrugadministrationroute058drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

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_id39050cb4-28d1-4305-a653-e5e50098c824spl_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

2)

drugcharacterization1medicinalproductHUMIRAdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberBLA125057Brand NameHUMIRAGeneric NameADALIMUMABManufacturersAbbVie Inc.product_ndc 0074-0067, 0074-3799, 0074-6347, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 351290, 352334, 727703, 727705, 763564, 763565, 797544, 825169, 825170, 1551887, ... spl_id1b259c93-37f5-4845-92ff-224dacfe1d50spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

3)

drugcharacterization2medicinalproductCELEBREXdrugstructuredosagenumb200drugstructuredosageunit003drugdosagetext200 MG, UNKdrugdosageformCAPSULE

openFDA Info on Medication

Application NumberNDA020998Brand NameCELEBREXGeneric NameCELECOXIBManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0025-1515, 0025-1520, 0025-1525, 0025-1530Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCELECOXIBRXCUI205322, 205323, 213468, 213469, 349514, 352314, 686379, 686381spl_idaa50b33d-5037-4cd8-968a-b0f64f8fb490spl_set_id8d52185d-421f-4e34-8db7-f7676db2a226Package NDC 0025-1515-01, 0025-1520-31, 0025-1520-51, 0025-1520-34, 0025-1525-31, 0025-1525- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIJCX84Q7J1L

4)

drugcharacterization2medicinalproductVOLTAREN /00372301/drugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, UNKdrugdosageformTABLET

5)

drugcharacterization2medicinalproductFLUCONAZOLEdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, UNKdrugdosageformTABLET

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

6)

drugcharacterization2medicinalproductFUROSEMIDEdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, UNKdrugdosageformTABLET

openFDA Info on Medication

Application Number ANDA077293, ANDA207552, ANDA213902, NDA016273, ANDA070655, ANDA212174, ANDA07043 ... Brand Name TOXYCOLOGY MEDICATED COLLECTION SYSTEM, FUROSEMIDE, LASIX, DIASCREEN 12-PANEL ME ... Generic NameFUROSEMIDEManufacturers IT3 Medical LLC, Amneal Pharmaceuticals LLC, Gland Pharma Limited, Validus Pharm ... product_ndc 70529-549, 70121-1076, 70121-1163, 70121-1164, 68083-432, 68083-433, 68083-434, ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 310429, 1038558, 1719286, 1719290, 1719291, 197732, 200801, 200809, 205732, 3139 ... spl_id 29531d06-4e7f-4e26-93d0-1d98e58966d2, c22d0330-1b76-420a-a84b-8ea59f8733a7, e7bd ... spl_set_id a78407a8-3d3e-4eb5-9e3f-b32a1b8015e4, d5b9f12e-d1e9-42de-90f2-c9ba33a86457, 6447 ... Package NDC 70529-549-01, 70529-061-08, 68345-883-50, 70121-1163-1, 70121-1163-5, 70121-1164 ... RouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsFUROSEMIDENUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

7)

drugcharacterization2medicinalproductHYDROMORPHONEdrugstructuredosagenumb2drugstructuredosageunit003drugdosagetext2 MG, UNKdrugdosageformTABLET

8)

drugcharacterization2medicinalproductSYSTANEdrugdosagetextUNKdrugdosageformGEL

openFDA Info on Medication

Application Numberpart349Brand NameSYSTANE ULTRA, SYSTANEGeneric Name POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL, POLYETHYLENE GLYCOL AND PROPYLENE ... ManufacturersAlcon Laboratories, Inc., Alcon Research Ltdproduct_ndc0065-1432, 0065-0431, 0065-0474, 0065-0454Product TypeHUMAN OTC DRUGRouteOPHTHALMICActive IngredientsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL, HYPROMELLOSE 2910 (4000 MPA.S)RXCUI477589, 310932, 895753spl_id 88c481ca-edb6-41aa-87f4-8b4f7e298b83, acaecb0f-4383-4e2a-9e6a-485d97247937, e26b ... spl_set_id a5c1c194-3db5-4f18-9cd1-97f7f84c3cff, 14916d2c-a63d-491e-bd91-a61f300af38a, 5f74 ... Package NDC 0065-1432-01, 0065-1432-02, 0065-1432-03, 0065-1432-04, 0065-1432-05, 0065-1432- ... UNIIB697894SGQ, 6DC9Q167V3, RN3152OP35

9)

drugcharacterization2medicinalproductVIVELLE /00045401/drugstructuredosagenumb.1drugstructuredosageunit003drugdosagetext0.1 MG, UNK

10)

drugcharacterization2medicinalproductAFRIN /00070001/drugstructuredosagenumb.05drugstructuredosageunit030drugdosagetext0.05 %, UNK

11)

drugcharacterization2medicinalproductSUMATRIPTANdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNKdrugdosageformTABLET

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]

12)

drugcharacterization2medicinalproductATENOLOLdrugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, UNKdrugdosageformTABLET

openFDA Info on Medication

Application Number NDA018240, ANDA078512, ANDA213136, ANDA077443, ANDA076900, ANDA073457, ANDA07405 ... Brand NameTENORMIN, ATENOLOLGeneric NameATENOLOLManufacturers Almatica Pharma LLC, Aurobindo Pharma Limited, Unichem Pharmaceuticals (USA), In ... product_ndc 52427-429, 52427-430, 52427-431, 65862-168, 65862-169, 65862-170, 29300-410, 293 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATENOLOLRXCUI150750, 152414, 197379, 197380, 197381, 201322spl_id 1b1cbfbf-b6bc-d1f8-d245-c6c68cda33f3, 5d59c0f7-9ff3-4dff-96b6-da6ebe996a8e, 29c4 ... spl_set_id 746db603-a6e1-4dc3-c2d8-92314419098c, 1b8a4689-3916-4f4b-b54a-bbb4e322d79b, 35d9 ... Package NDC 52427-429-90, 52427-430-90, 52427-431-90, 65862-168-01, 65862-168-99, 65862-169- ... NUIN0000000161, N0000175556Mechanism of ActionAdrenergic beta-Antagonists [MoA]Established Pharmacologic Classbeta-Adrenergic Blocker [EPC]UNII50VV3VW0TI

13)

drugcharacterization2medicinalproductCLONAZEPAMdrugstructuredosagenumb.5drugstructuredosageunit003drugdosagetext0.5 MG, UNKdrugdosageformTABLET

openFDA Info on Medication

Application Number ANDA077194, ANDA077171, ANDA074569, ANDA077147, ANDA211033, ANDA077856, NDA01753 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Teva Pharmaceuticals USA, Inc., Par Pharmaceutical, Inc., Accord Healthcare Inc. ... product_ndc 0093-9290, 0093-9291, 0093-9292, 0093-9293, 0093-9294, 49884-306, 49884-307, 498 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id 0a290597-0942-4e2e-bcf7-7486bf8b933e, a95f8799-0bb3-41d6-aa27-8a291127ad54, e7a6 ... spl_set_id cb2e209e-e69b-422b-8abb-34df2bc92caa, 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069 ... Package NDC 0093-9290-67, 0093-9291-67, 0093-9292-67, 0093-9293-67, 0093-9294-67, 49884-306- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

14)

drugcharacterization2medicinalproductCLINDAMYCINdrugstructuredosagenumb150drugstructuredosageunit003drugdosagetext150 MG, UNKdrugdosageformCAPSULE

openFDA Info on Medication

Application Number ANDA090108, ANDA090109, ANDA204748, ANDA204749, NDA050782, ANDA203048, ANDA06534 ... Brand NameCLINDAMYCIN, CLINDAGELGeneric NameCLINDAMYCIN PHOSPHATE, CLINDAMYCINManufacturers Sagent Pharmaceuticals, Mylan Institutional LLC, Bausch Health US, LLC, Akorn, F ... product_ndc 25021-115, 67457-814, 67457-815, 67457-816, 67457-817, 16781-462, 17478-120, 174 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, TOPICALActive IngredientsCLINDAMYCIN PHOSPHATE, CLINDAMYCINRXCUI205964, 1737244, 1737578, 1737581, 309332, 351330, 309335, 309336, 309339spl_id 5247d748-763d-48dc-90dc-3e25f4211a6c, 1152ed95-2f9f-4dae-9f23-4bc591601cf5, 4703 ... spl_set_id 7a6967b3-5563-4bed-9eee-d400f800e799, 458e043d-6584-4503-b398-2032d3cce2f1, e842 ... Package NDC 25021-115-02, 25021-115-04, 25021-115-06, 25021-115-51, 67457-814-00, 67457-814- ... UNIIEH6D7113I8, 3U02EL437CNUIN0000009982, N0000175443, M0515779, N0000175731Physiologic/Pharmacodynamic EffectDecreased Sebaceous Gland Activity [PE], Neuromuscular Blockade [PE]Established Pharmacologic ClassLincosamide Antibacterial [EPC]Chemical StructureLincosamides [CS]

15)

drugcharacterization2medicinalproductFOSINOPRILdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKdrugdosageformTABLET

openFDA Info on Medication

Application NumberANDA077222Brand NameFOSINOPRIL SODIUMGeneric NameFOSINOPRILManufacturersCipla USA Inc.product_ndc69097-856, 69097-857, 69097-858Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFOSINOPRIL SODIUMRXCUI857169, 857183, 857187spl_id7c39fc9f-bccb-4cab-acc3-89e1d7af8d9espl_set_id736fe52f-69fb-48b2-b1c5-f06531878538Package NDC 69097-856-05, 69097-856-15, 69097-857-05, 69097-857-15, 69097-858-05, 69097-858- ... UNIINW2RTH6T2N

16)

drugcharacterization2medicinalproductRANITIDINEdrugstructuredosagenumb75drugstructuredosageunit003drugdosagetext75 MG, UNKdrugdosageformTABLET

openFDA Info on Medication

Application Number ANDA078653, NDA021698, ANDA075208, ANDA078192, ANDA075294, ANDA075167, ANDA07854 ... Brand Name RANITIDINE, ZANTAC 150 ACID REDUCER, RANITIDINE 75, RANITIDINE IMMEDIATE RELEASE ... Generic NameRANITIDINE, RANITIDINE HYDROCHLORIDEManufacturers Wockhardt USA LLC., Lil' Drug Store Products, Inc, Dr. Reddy's Laboratories Limi ... product_ndc 64679-741, 66715-9736, 64679-906, 64679-907, 55111-404, 55111-131, 60505-0160, 6 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRANITIDINE HYDROCHLORIDE, RANITIDINERXCUI198191, 827189, 198193, 312773, 705610, 198190, 198192spl_id b389e8a7-8065-48f9-a0bc-fb30bed04c2d, b595216b-d636-7f28-e053-2a95a90a40bc, 76be ... spl_set_id f7aa08fc-5d10-4067-8f20-3c3e176e3e35, 5e569962-0763-4669-96c2-93012ff6cd6c, da16 ... Package NDC 64679-741-01, 64679-741-02, 64679-741-05, 64679-741-03, 64679-741-06, 64679-741- ... UNIIBK76465IHM, 884KT10YB7NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]

17)

drugcharacterization2medicinalproductPROMETHAZINEdrugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, UNKdrugdosageformTABLET

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

18)

drugcharacterization2medicinalproductNYSTATINdrugdosagetextCRE 100000

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

19)

drugcharacterization2medicinalproductLEVOTHYROXINdrugstructuredosagenumb25drugstructuredosageunit004drugdosagetext25 MUG, UNKdrugdosageformTABLET

20)

drugcharacterization2medicinalproductNEXIUM /01479302/drugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, UNKdrugdosageformCAPSULE

21)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb1drugstructuredosageunit003drugdosagetext1 MG, UNKdrugdosageformTABLET

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

22)

drugcharacterization2medicinalproductL METHYLFOLATEdrugdosagetext15drugdosageformCAPSULE

23)

drugcharacterization2medicinalproductADDERALLdrugstructuredosagenumb15drugstructuredosageunit003drugdosagetext15 MG, UNKdrugdosageformCAPSULE

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

24)

drugcharacterization2medicinalproductMAALOX /00082501/drugdosagetextUNK

25)

drugcharacterization2medicinalproductVITAMIN D2drugdosagetext400 UNIT, UNKdrugdosageformTABLET

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

26)

drugcharacterization2medicinalproductDOXYCYCLINEdrugstructuredosagenumb75drugstructuredosageunit003drugdosagetext75 MG, UNKdrugdosageformCAPSULE

openFDA Info on Medication

Application Number ANDA201678, ANDA204234, ANDA065053, ANDA210664, ANDA065285, NDA050805, ANDA06545 ... Brand NameDOXYCYCLINE, ORACEA, VIBRAMYCIN MONOHYDRATE, DOXY 100, DOXYCYCLINE HYCLATEGeneric NameDOXYCYCLINE, DOXYCYCLINE HYCLATEManufacturers Lupin Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc., Acella Pharmac ... product_ndc 68180-657, 68180-650, 68180-651, 68180-652, 63304-614, 63304-615, 63304-616, 421 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsDOXYCYCLINE, DOXYCYCLINE HYCLATERXCUI 1650030, 700408, 1649401, 1649990, 1650143, 1649429, 1650142, 1650444, 1652673, ... spl_id c09eb87b-5a56-4166-a905-f2bac5fcd4b2, e4e6b036-db43-4695-bbfe-3aea1790b67e, d87f ... spl_set_id e0e80435-1b6a-4361-8c8a-e432f8f23a1b, bcc65910-30d8-4807-ab61-607a56382924, 829d ... Package NDC 68180-657-01, 68180-650-01, 68180-651-01, 68180-652-08, 68180-652-29, 63304-614- ... NUIN0000175882, N0000007948Established Pharmacologic ClassTetracycline-class Drug [EPC]Chemical StructureTetracyclines [Chemical/Ingredient]UNIIN12000U13O, 19XTS3T51U, 8ZL07I20SB