Alopecia, Erythema, Pruritus
Drugs: ROSUVASTATIN CALCIUM, BI-EST/TEST-U 1.0/2mg/ml cream, progesterone RDT 100 mg +7
- Safetyreportversion
- 1
- Safetyreportid
- 26917344
- Primarysourcecountry
- US
- Transmissiondateformat
- 102
- Transmissiondate
- 20260709
- Reporttype
- 1
- Serious
- 2
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 2
- Receivedateformat
- 102
- Receivedate
- 20260623
- Receiptdateformat
- 102
- Receiptdate
- 20260623
- Fulfillexpeditecriteria
- 3
- Authoritynumb
- 828119
- Primarysource
- Reportercountry
- US
- Qualification
- 5
- Sender
- Sendertype
- 6
- Senderorganization
- FDA-CTU
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 67
- Patientonsetageunit
- 801
- Patientweight
- 58.5
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Alopecia
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Erythema
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Pruritus
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- ROSUVASTATIN CALCIUM
- Drugdosagetext
- OTHER QUANTITY : 1 TABLET(S);
- Drugadministrationroute
- 048
- Drugindication
- Blood cholesterol increased
- Drugstartdateformat
- 102
- Drugstartdate
- 20260305
- Drugenddateformat
- 102
- Drugenddate
- 20260617
- Drugadditional
- 2
- Activesubstance
- Activesubstancename
- ROSUVASTATIN CALCIUM
- Harmonized identifiers (openFDA)
- Application number
- ANDA212059, ANDA208898, ANDA079170, ANDA207626, ANDA079172, ANDA207752, ANDA207375, ANDA206465, ANDA201619, ANDA207408, ANDA207453, ANDA210667, ANDA207062
- Brand name
- ROSUVASTATIN CALCIUM
- Generic name
- ROSUVASTATIN CALCIUM
- Manufacturer name
- Zhejiang Yongtai Pharmaceutical Co., Ltd., Quallent Pharmaceuticals Health LLC, Novadoz Pharmaceuticals LLC, Rising Pharma Holdings, Inc., Umedica Laboratories USA Inc., NorthStar Rx, LLC, Glenmark Pharmaceutials Inc., USA, PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS, Shandong New Time Pharmaceutical Co., Ltd., Ascend Laboratories, LLC, NorthStar RxLLC, Torrent Pharmaceuticals Limited, Cranbury Pharmaceuticals, LLC, Biocon Pharma Inc, Cadila Pharmaceuticals Limited, Aurobindo Pharma Limited, HEC Pharm USA Inc., Westminster Pharmaceuticals, LLC, TORRENT PHARMACEUTICALS LIMITED
- Product NDC
- 69434-005, 69434-006, 69434-007, 69434-008, 82009-017, 82009-018, 82009-019, 82009-020, 72205-002, 72205-003, 72205-004, 72205-005, 72205-027, 57237-168, 57237-169, 57237-170, 57237-171, 60290-043, 60290-044, 60290-045, 60290-046, 72603-364, 72603-365, 72603-366, 72603-367, 68462-261, 68462-262, 68462-263, 68462-264, 24658-261, 24658-262, 24658-263, 24658-264, 42677-301, 42677-302, 42677-303, 42677-304, 67877-439, 67877-440, 67877-441 +37 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- ROSUVASTATIN CALCIUM
- RxCUI
- 859419, 859424, 859747, 859751
- SPL ID
- f378d351-0576-4496-baca-a2858712bc5c, 86597300-9b2c-44cf-9650-503f5bdbf5bb, 62787a4a-6d53-43a3-a0b7-ed0b6037d18e, 05d54625-511b-4cba-818b-e77e3e6b17a3, 5368ad40-da32-8cfd-e063-6294a90ae598, 54957f99-e5ff-dbab-e063-6294a90ad4cd, 760efcac-6dbc-4e58-b2cc-9fc5f9b5603f, 39b848aa-fb65-4b04-916c-1c83589ff3ce, 52c7b3fe-56c6-3cd9-e063-6294a90acfbb, e6a44b24-b851-40c2-92ef-ee7e9fe0d2db, af3a6349-8b25-462d-9fbf-3e95c32734df, a922bb47-91e3-4103-9edb-d9431a38d398, 6c4547c4-9429-42e5-998f-e97f6a74f150, 843cb1f2-e29f-1cea-4a98-e34470827fba, 1fa3517d-f34d-430d-89e0-8b4c9d923f77, 3073eb2c-5f7f-46ec-81aa-97db900472eb, 57a6409f-9fd1-54ae-e063-6294a90ae490, 447c034b-bd46-2a37-e063-6394a90a4feb, 5a7f22c1-173a-e853-e063-6394a90a4556
- SPL set ID
- 40c2900e-4659-49ce-ba4b-5df529b3c53b, 6f978191-775e-4745-9c07-99e5be888afe, d58f1f63-4bb6-413c-9730-ded3e8078618, 5c992d3d-d754-48b6-a267-1451208352ed, 989dffcf-0254-439d-9f3f-3b0e9d32de0a, c622757d-7370-438b-8c2d-ef444a4f31dd, 392657a9-955c-42c2-814c-1890ece45afa, 9333c674-5714-41ed-8a16-dc7c3e50b9a4, ae865404-ecf4-41a8-b40b-62f887c220f2, 4ccbaa83-d57a-421e-88a8-1cee42d4207b, 17d71c80-fade-4735-acec-60738d26dd01, 8c2d481f-53f2-4cf6-bd28-7d92323785cd, 606d16fb-82e4-420d-9456-09997562b528, 033d8c8f-bbe9-96b5-fd53-cb0ef929857a, 6802a946-a29c-4d41-997b-3c078ed8e74d, 47924917-bbd5-45de-96cb-c7ff9754da97, 568a782b-1621-5e59-e063-6294a90a7fef, 02797697-300a-43db-92cf-9b78f08626be, 6985e729-d963-4f32-89a1-727472b86daa
- Package NDC
- 69434-005-02, 69434-005-03, 69434-006-02, 69434-006-03, 69434-007-02, 69434-007-03, 69434-008-01, 69434-008-03, 82009-018-90, 82009-018-10, 82009-019-90, 82009-019-10, 82009-020-30, 82009-020-10, 82009-017-90, 82009-017-10, 72205-003-90, 72205-003-99, 72205-003-11, 72205-003-06, 72205-003-05, 72205-004-90, 72205-004-99, 72205-004-11, 72205-004-06, 72205-004-05, 72205-005-30, 72205-005-90, 72205-005-99, 72205-005-11, 72205-005-06, 72205-005-05, 72205-027-90, 72205-027-99, 72205-027-11, 72205-027-06, 72205-027-05, 72205-002-90, 72205-002-99, 72205-002-11 +208 more
- UNII
- 83MVU38M7Q
- Drugcharacterization
- 2
- Medicinalproduct
- BI-EST/TEST-U 1.0/2mg/ml cream
- Drugcharacterization
- 2
- Medicinalproduct
- progesterone RDT 100 mg
- Drugcharacterization
- 2
- Medicinalproduct
- Super Methyl-SP (K-112) mulitvitamin
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- FREQUENCY : DAILY;
- Drugcharacterization
- 2
- Medicinalproduct
- Vitamin D (K-2) Ortho Molecular (600 IU) per drop liquid
- Drugcharacterization
- 2
- Medicinalproduct
- TRU Niagen 300 mg
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- FREQUENCY : DAILY;
- Drugcharacterization
- 2
- Medicinalproduct
- DHEA tabs Ortho Molecular 5 mg
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- FREQUENCY : DAILY;
- Drugcharacterization
- 2
- Medicinalproduct
- BPC-157 Pure oral spray
- Drugdosagetext
- OTHER FREQUENCY : 2 PUMPS DAILY;
- Drugcharacterization
- 2
- Medicinalproduct
- Adrenal RLC Labs
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- OTHER STRENGTH : 2 TABS;?FREQUENCY : DAILY;
- Drugcharacterization
- 2
- Medicinalproduct
- Berberine ES-5
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- OTHER STRENGTH : 1 TAB;?FREQUENCY : DAILY;
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260601