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Trade Name | KANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMN |
Classification Name | beta 2-microglobulin apheresis column |
Generic Name | beta 2-microglobulin apheresis column |
Applicant |
KANEKA PHARMA AMERICA LLC |
546 fifth ave., 21st floor |
new york, NY 10036 |
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HDE Number | H130001 |
Supplement Number | S001 |
Date Received | 04/02/2015 |
Decision Date | 08/24/2015 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | postapproval study protocol - osb |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the post-approval study protocol. |