UVADEX(R) STERILE LIQUID
FDA premarket approval P860003/S033 · decided 2000-03-06
Approval details
- PMA number
- P860003
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- UVADEX(R) STERILE LIQUID
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 1999-09-07
- Decision date
- 2000-03-06
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Approval for a labeling change to reflect the use of UVADEX, the sterile liqud formulation of 8-methoxypsoralen.
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