TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY
FDA premarket approval P890025/S010 · decided 1998-02-13
Approval details
- PMA number
- P890025
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY
- Generic name
- Fluorescence polarization immunoassay for cyclosporine
- Applicant
- Abbott Laboratories
- Date received
- 1997-03-03
- Decision date
- 1998-02-13
- Days to decision
- 347 days
- Decision code
- APPR
- Product code
- MGU
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- Approval for change in monoclonal antibody manufacturing site from Sandoz Pharmaceuticals AG., Switzerland to Abbott Laboratories, Abbott Park, IL USA, under the trade name TDx(R)/TDxFLx(R) Cyclosporine Monoclonal Whole Blood Assay, It is indicated for the quantitative measurement of cyclosporine as an aid in the management of cardiac, liver, and renal transplant patients.
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