Enterocolitis
Drugs: OXALIPLATIN, CAPECITABINE
- Safetyreportversion
- 1
- Safetyreportid
- 27325210
- Primarysourcecountry
- CA
- Occurcountry
- CA
- Transmissiondateformat
- 102
- Transmissiondate
- 20261010
- Reporttype
- 2
- Serious
- 1
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 1
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 1
- Receivedateformat
- 102
- Receivedate
- 20260930
- Receiptdateformat
- 102
- Receiptdate
- 20260930
- Fulfillexpeditecriteria
- 1
- Companynumb
- CA-TEVA-VS-3495714
- Duplicate
- 1
- Reportduplicate
- Duplicatesource
- Health Canada
- Duplicatenumb
- E2B_08806225
- Duplicatesource
- Market Authorization Holder AER Number
- Duplicatenumb
- 2026AP005541
- Primarysource
- Reportercountry
- CA
- Qualification
- 3
- Sender
- Sendertype
- 6
- Senderorganization
- TEVA PHARMACEUTICALS INDUSTRIES LTD.
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientagegroup
- 5
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Enterocolitis
- Reactionoutcome
- 6
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- OXALIPLATIN
- Drugauthorizationnumb
- 022160
- Drugseparatedosagenumb
- 1
- Drugindication
- Colorectal cancer
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- OXALIPLATIN
- Harmonized identifiers (openFDA)
- Application number
- ANDA207325, ANDA217925, ANDA203869, ANDA207474, ANDA204616, ANDA217348, ANDA204368, ANDA078817, ANDA078813, ANDA219765, ANDA091358, ANDA205529, ANDA207385
- Brand name
- OXALIPLATIN
- Generic name
- OXALIPLATIN
- Manufacturer name
- Meitheal Pharmaceuticals Inc., FOSUN PHARMA USA INC., Gland Pharma Limited, Camber Pharmaceuticals, Inc., Sagent Pharmaceuticals, Accord Healthcare Inc., Qilu Pharmaceutical Co., Ltd., Sandoz Inc, Hospira, Inc., Apotex Corp., Shandong New Time Pharmaceutical Co., Ltd., Mylan Institutional LLC, BluePoint Laboratories, Baxter Healthcare Corporation, Northstar Rx LLC, Eugia US LLC, NorthStar Rx LLC
- Product NDC
- 71288-149, 72266-161, 72266-162, 68083-176, 68083-177, 68083-314, 31722-357, 31722-358, 71288-101, 25021-233, 16729-332, 67184-0501, 67184-0502, 71288-171, 71288-172, 67184-0508, 67184-0509, 67184-0510, 0781-3315, 0781-3317, 61703-363, 60505-6132, 42677-336, 42677-337, 67457-442, 67457-469, 68001-468, 60505-6287, 43066-014, 43066-018, 72603-320, 72603-420, 55150-331, 55150-332, 72603-101, 72603-301, 68083-170, 68083-171, 0781-9315, 0781-9317
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- OXALIPLATIN
- RxCUI
- 1736776, 1736781, 1797528, 1736784, 1736786
- SPL ID
- fb8d544c-a5df-4648-9422-9d53141d3a70, 2b48f7c2-8c48-6b82-e063-6394a90a3baf, e90dd0c2-1d2b-42e8-bde6-85718a5b90b9, 3fee20f4-5fee-8b4e-e063-6294a90a1a0a, d6861b65-5f18-4217-91b5-132425791d90, c159050a-e588-4091-b9ee-ea502e1b9529, 0e2ec613-5375-858e-e063-6294a90ab95a, f9f54aa0-22e3-4958-b368-d89d716ac2fa, 50b4c21f-714a-4a01-bf28-a856b19914d1, e78605b3-b28b-4634-9a58-d4bda67832ba, f3766495-fce3-461c-8c95-e890f5e3383f, 4edbffab-0628-4c35-ac6a-76a629f3c9dd, 3960461c-958a-43c1-a685-522039b021df, 4f6846af-385e-b624-e063-6394a90a28d7, 01a705c0-0014-4a63-aa66-918cdcc2df67, a675c4d7-bb27-4a92-8b10-dbae3a4ceb2b, 2ee49254-54a3-0865-e063-6294a90a2974, e56ed9d9-cd5b-4ba2-82a3-eb805fbc1a5b, e6815a98-0efc-4d69-8612-9e7ab7e78c0a, 9ebe158f-dd21-4bb8-ac13-d18162773cef, faf81c5b-2d7e-4e6f-825b-f8a8399c0066, f7b91231-4045-45a6-97c3-72fa9deaccf6, 0d039035-85d1-40d4-8ee6-540026ab7a5c, ac83b4cd-5026-4dd5-b733-125d28ba3c95
- SPL set ID
- 7e38318e-c569-4ad4-8f10-a235f30444d1, fad0f147-6595-4412-87a7-2afca0192a96, a6f89dc3-a594-4b5b-8728-272e20c1ecb5, b0799e39-7b1e-430a-b159-062b39521001, 873fa936-157a-4f85-bc70-5df31d71d122, 29a5d098-bfa7-4a65-bb4f-5daa1fef1c2f, 4b805925-beb1-2bac-e054-00144ff88e88, e9e47f3c-9acc-44f5-b0bd-d26fe9d35d64, ee2e0da9-5ae7-405b-8dd1-635be72bc439, 33d4f4b4-bb4e-46af-9e89-df20154436d0, ab162009-6f84-4d56-ab56-5e84409ec814, e51a62ba-d163-4c57-835c-8c86cf097e40, ee5a5a1d-63f6-4d5a-901b-65be45ec6610, 1ac38523-480b-4c0f-97a1-7dfa1432923c, da0e8523-609a-4326-96b1-d7de78662d91, 11377169-7986-45b1-8298-6f0533efa3c3, b6083405-9b45-4d2c-e053-2995a90ad9ef, bb180ec5-1f75-43c1-9f63-c0657af2ca5f, 21a2bb1d-d91d-4f99-97dd-cc67fe99a090, 7dc8dfb1-dec8-43b3-b2ea-05eac054b2c6, 1bb4febd-0ed4-48c9-ba2a-e22183a2143f, f299b2d2-86ed-4fb8-822e-65455a0bb75a, d6178bc6-9dae-413f-8f47-de75d576c5b8, 86f6c19d-30d1-42e3-8d46-5e3f45776e85
- Package NDC
- 71288-149-95, 71288-149-96, 72266-161-01, 72266-162-01, 68083-176-01, 68083-177-01, 68083-314-01, 31722-357-10, 31722-358-20, 71288-101-10, 71288-101-20, 25021-233-10, 25021-233-20, 16729-332-03, 16729-332-05, 16729-332-35, 67184-0501-1, 67184-0502-1, 71288-171-11, 71288-172-21, 67184-0508-1, 67184-0509-1, 67184-0510-1, 0781-3315-70, 0781-3317-80, 61703-363-18, 61703-363-22, 60505-6132-6, 60505-6132-7, 60505-6132-8, 42677-337-01, 42677-337-10, 42677-336-01, 42677-336-10, 67457-469-10, 67457-442-20, 71288-171-91, 71288-172-92, 68001-468-36, 68001-468-37 +14 more
- Nui
- N0000175413, N0000175073
- Pharm class epc
- Platinum-based Drug [EPC]
- UNII
- 04ZR38536J
- Drugcharacterization
- 1
- Medicinalproduct
- CAPECITABINE
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- DOSE FORM: NOT SPECIFIED
- Drugindication
- Colorectal cancer
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- CAPECITABINE
- Harmonized identifiers (openFDA)
- Application number
- ANDA209365, ANDA210203, ANDA204345, ANDA091649, ANDA217237, ANDA207456, ANDA202593, ANDA211724, ANDA207652, ANDA210604, NDA020896, ANDA204668
- Brand name
- CAPECITABINE, CAPECITABINE 150MG, XELODA, CAPECITABINE 500MG
- Generic name
- CAPECITABINE
- Manufacturer name
- Cipla USA Inc., BluePoint Laboratories, Dr. Reddy's Laboratories Limited, NorthStar RxLLC, Teva Pharmaceuticals USA, Inc., Teyro Labs Private Limited, Armas Pharmaceuticals Inc., Accord Healthcare Inc., Lifestar Pharma LLC, Novadoz Pharmaceuticals LLC, Ascend Laboratories, LLC, Aurobindo Pharma Limited, H2-Pharma, LLC, Camber Pharmaceuticals, Inc., CivicaScript LLC, Quallent Pharmaceuticals Health LLC, Sun Pharmaceutical Industries, Inc.
- Product NDC
- 69097-948, 69097-949, 68001-643, 68001-644, 55111-496, 55111-497, 72603-303, 0093-7473, 0093-7474, 82511-001, 82511-002, 72485-204, 16729-072, 16729-073, 70756-815, 70756-816, 72205-006, 72205-007, 67877-458, 67877-459, 59651-204, 59651-205, 61269-475, 61269-470, 31722-774, 31722-775, 82249-207, 82249-210, 82009-112, 62756-238, 62756-239, 72485-205
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- CAPECITABINE
- RxCUI
- 200327, 200328, 213292, 213293
- SPL ID
- c1549b67-948e-402d-9ba4-6fc16237df8f, 498ba415-dab9-ce68-e063-6394a90af1b4, 25eb47d5-42ca-889b-6798-6f91d7795417, 571e3d84-50ae-dfbc-e063-6294a90a1d9b, 94cd2146-70ff-43e3-a896-b9e55d75540f, 2b3f98b5-d81c-d87d-e063-6294a90a7e87, 680dac89-d210-4eb8-a955-bf40e652c546, 0e1e6b8e-1e8f-3b26-e063-6294a90ad5fb, 42b31bbf-e149-216a-e063-6394a90ae1d5, 136d5048-1342-4a83-b6ce-db9f8933741c, b664d5bf-34cd-480f-a055-e403628a4889, eee71cc5-a7d5-4e51-ab02-2fae12418585, 32dd0155-c5cb-49c2-9b74-74f40df22df7, 519e85b4-ff10-917f-e063-6394a90a12df, 5a175994-25a9-4271-957f-9d8cc02fbfce, 752dff9e-8c95-001e-3602-7da1217d21bc, 8a24ef3b-b59a-4051-bf0d-a98eb6187ef2, dad6f70f-70c9-4152-bd36-9cb3537239da
- SPL set ID
- 2871c37d-5e55-437b-a434-fc86d845492a, 88c5af84-900a-4372-b056-bfea70c129cf, 007e3432-c8aa-2a76-52ba-c346924c08a7, 0b59e98c-5b34-4b93-90f6-20526f4d4f88, 5753679a-506c-4ac4-b8b2-b27c664d1d40, 0c873e5b-51c2-4685-86c5-53f98563b093, 7f555b6b-60db-45e2-a61e-537e57f43fdc, 8345d55e-ad02-4726-a04b-1a46e3337a4b, 643a31d6-0e30-4602-a9b4-355fe944bfea, 29885ada-b743-419c-8f15-edd4247c76ca, 06a88b03-6c06-4dae-b3bc-1e8dd81c9067, 56441153-a1e5-4fdc-96d6-f21baa6b5fbe, e702d84d-7162-4751-bf37-d724cc7e45a5, 3e7d6317-1439-4976-ae00-6f62619ec3dd, 4ec2cfc1-e8ca-4109-8b90-1aab07cbab21, d23f023a-ea62-4ac0-f615-d5d26d59526d, e3b1a2b5-f1ce-45ea-afd8-68aac53665fa, f050d16c-ab76-489d-b92c-8c155b4e3f7c
- Package NDC
- 69097-949-03, 69097-948-08, 68001-643-06, 68001-644-07, 55111-496-60, 55111-496-05, 55111-497-04, 55111-497-05, 72603-303-01, 0093-7473-06, 0093-7474-89, 82511-001-15, 82511-002-50, 72485-204-60, 16729-072-12, 16729-073-29, 70756-815-60, 70756-816-22, 72205-006-60, 72205-007-92, 67877-458-30, 67877-458-60, 67877-458-12, 67877-459-30, 67877-459-60, 67877-459-12, 59651-204-60, 59651-204-10, 59651-205-08, 59651-205-10, 61269-470-60, 61269-475-12, 31722-774-60, 31722-775-12, 31722-775-60, 82249-207-60, 82249-210-12, 82009-112-12, 62756-238-86, 62756-238-88 +5 more
- Nui
- N0000000233, N0000175595
- Pharm class moa
- Nucleic Acid Synthesis Inhibitors [MoA]
- Pharm class epc
- Nucleoside Metabolic Inhibitor [EPC]
- UNII
- 6804DJ8Z9U