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April 17, 2023 Summary Basis for Regulatory Action - OMISIRGE
… 20 mL of cryopreservation solution containing 10% dimethyl sulfoxide, filtered across a filter directly into the … 10 mL of cryopreservation solution containing 10% dimethyl sulfoxide, filtered across a filter directly into …
Package Insert - SKYSONA
… of body weight, suspended in a solution containing 5% dimethyl sulfoxide (DMSO). (3) … reactions may occur with the infusion of SKYSONA. The dimethyl sulfoxide (DMSO) in SKYSONA may cause …
September 21, 2023 Endocrinologic and Metabolic Drugs Advisory Committee- FDA Presentations
… powder with markedly higher viscosity compared to the dimethyl sulfoxide-based solution of Viadur • The device does not have …
June 24, 2022 Clinical Review Memorandum - BREYANZI
… DLCO Diffuse capacity of the lung for carbon monoxide DMSO Dimethyl sulfoxide DoCR Duration of complete response DOR Duration of …
LIB4645.pdf
… metabolite C7H14N2O4S 3.6 245.05665 (Na+) Aldicarb Sulfoxide Carbamate metabolite C7H14N2O3S 2.3 229.06173 (Na+) … in use such as benzylalkonium chlorides (BAC), dichloro- dimethyl hydantoin (DCDMH), dibromo-dimethyl hydantoin (DBDMH), and trichloroisocyanuric acid …
GRAS Notice 1072 with Amendments
… matter basis DMBA 7,12-dimethylbenz-alpha-anthracene DMSO Dimethyl sulfoxide DNA Deoxyribonucleic acid EAA Essential amino acid …
Current LIB Index
… 3/16/66 190 Analysis of Emtryl Tablets Containing 1,2-Dimethyl-5-Nitroimidazole 3/16/66 191 Polarographic Method … 3/16/66 224 Safety Practices Involving the Use of Dimethyl Sulfoxide (DMSO)With Pesticides 3/16/66 225 False …
Package Insert - cobas Zika
… MMX-R2) Tricine buffer, potassium acetate, glycerol, 18% dimethyl sulfoxide, …
Clinical Review Memo - SKYSONA
… etc. suspended, and cryopreserved, containing 5% dimethyl sulfoxide Dosage Form(s) and A suspension for intravenous …
Right Value Drug Store, Inc. dba Carie Boyd’s Prescription Shop, Hurst, TX. Untitled Letter dated 10/25/2019
… triglycerides, tryptophan, xanthan gum, zinc chloride, dimethyl sulfoxide (DMSO), belladona, DHEA, and leucovorin. Drug …
LIB4671.pdf
… only f) Formic Acid: LC/MS grade – (Fisher Scientific) g) Dimethyl sulfoxide (DMSO) – HPLC Grade (Fisher Scientific) h) …
October 1, 2021 Clinical Review and Evaluation - TECARTUS
… genetically modified autologous T cells in CryoStor (dimethyl sulfoxide [DMSO], final concentration, 5%), sodium chloride …
GRAS Notice 986
… CK-22: Chlorella Powder Cl: Chloride CRE: Creatinine DMSO: Dimethyl Sulfoxide EDI: Estimated Daily Intake FAAS: Flame Atomic …
Package Insert - cobas MPX
… MMX-R2) Tricine buffer, potassium acetate, glycerol, 18% dimethyl sulfoxide, Tween 20, EDTA, < 0.06% dATP, dGTP, dCTP, < 0.14% …
GRAS Notice 791
… procedures In Process 1, crude urolithin A is dissolved in dimethyl sulfoxide (DMSO) for a polish filtration and subsequently …
Accula SARS-Cov-2 Test (Mesa Biotech Inc.) - Instructions for Use
… Single-use vial of solution containing 5 mL of buffer with dimethyl sulfoxide and < 0.01% sodium azide. • Transfer Pipette (25): …
cobas MPXV for use on the cobas 6800/8800 Systems (cobas MPXV) - Instructions for Use
… 2 (MPXV MMX-R2) Tricine buffer, potassium acetate, < 18% dimethyl sulfoxide, glycerol, < 0.1% Tween 20, EDTA, < 0.12% dATP, …
cobas SARS-CoV-2 Duo - IFU
… Duo MMX-R2) Tricine buffer, potassium acetate, < 18% dimethyl sulfoxide, glycerol, < 0.1% Tween 20, EDTA, < 0.12% dATP, …
cobas SARS-CoV-2 and Influenza A/B v2 - IFU
… v2 MMX -R2) Tricine buffer, potassium acetate, < 18% dimethyl sulfoxide, glycerol, < 0.1% Tween 20, EDTA, < 0.15% dATP, …
Package Insert - cobas WNV
… MMX-R2) Tricine buffer, potassium acetate, glycerol, 18% dimethyl sulfoxide, Tween 20, EDTA, < 0.06% dATP, dGTP, dCTP, < 0.14% …
Package Insert - cobas HIV-1/HIV-2 Qualitative
… MMX-R2) Tricine buffer, potassium acetate, 18% dimethyl sulfoxide, glycerol, Tween 20, EDTA, < 0.06% dATP, dCTP, …
package-insert-lenmeldy.pdf
… allergic reactions in children treated with LENMELDY. The dimethyl sulfoxide (DMSO) in LENMELDY may cause hypersensitivity …
Package Insert - CASGEVY (STN125785)
… reactions, including anaphylaxis, can occur due to dimethyl sulfoxide (DMSO) or dextran 40 in the cryopreservative …
Summary Basis for Regulatory Action - SKYSONA
… is formulated in cryopreservation solution containing 5% dimethyl sulfoxide (DMSO). The formulated drug product is filled into …
Package Insert - AMTAGVI
… 50% CryoStor CS10 (resulting in final concentration of 5% dimethyl sulfoxide (DMSO)), 2% of 25% human serum albumin (resulting …