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FDA BLA · BLA021271

IPRIVASK

Sponsor: BAUSCH

APPLICATION
BLA021271
TYPE
BLA
ORIGINAL APPROVAL
2003-04-04
LATEST ACTION
2015-05-18
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

IPRIVASKDiscontinued
DESIRUDIN RECOMBINANT 15MG/VIAL · INJECTABLE · SUBCUTANEOUS

Approval history

2015-05-18Manufacturing (CMC) · Supplement 7 · standardAP
2014-11-07Labeling · Supplement 6 · standard — Letter ↗AP
2014-07-01Manufacturing (CMC) · Supplement 5 · standardAP
2010-01-21Manufacturing (CMC) · Supplement 1AP
2003-04-04Type 2 - New Active Ingredient · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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