← FDA DRUG APPROVALS

FDA BLA · BLA020521

INFASURF

calfactant

Sponsor: ONY

APPLICATION
BLA020521
TYPE
BLA
ORIGINAL APPROVAL
1998-07-01
LATEST ACTION
2024-08-23
ROUTE
ENDOTRACHEAL, INTRATRACHEAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

INFASURF PRESERVATIVE FREEPrescription
CALFACTANT 35MG/ML · SUSPENSION · INTRATRACHEAL

Approval history

2024-08-23Labeling · Supplement 38 · standard — Label ↗AP
2015-03-09Manufacturing (CMC) · Supplement 28 · standardAP
2015-03-09Manufacturing (CMC) · Supplement 29 · standardAP
2014-03-11Manufacturing (CMC) · Supplement 27 · standardAP
2013-12-23Manufacturing (CMC) · Supplement 25 · standardAP
2013-10-18Manufacturing (CMC) · Supplement 26 · standardAP
2011-07-01Labeling · Supplement 24 · unknown — Letter ↗AP
2009-12-10Manufacturing (CMC) · Supplement 21AP
2002-12-12Manufacturing (CMC) · Supplement 8 · standard — Letter ↗AP
2002-09-13Manufacturing (CMC) · Supplement 11 · standardAP
2002-04-18Manufacturing (CMC) · Supplement 7 · standardAP
2002-04-18Manufacturing (CMC) · Supplement 6 · standardAP
2002-02-19Manufacturing (CMC) · Supplement 10 · standardAP
2001-11-20Manufacturing (CMC) · Supplement 9 · standardAP
2000-05-18Manufacturing (CMC) · Supplement 4 · standardAP
2000-02-23Manufacturing (CMC) · Supplement 3 · standardAP
1999-10-14Manufacturing (CMC) · Supplement 2 · standardAP
1999-03-17Manufacturing (CMC) · Supplement 1 · standardAP
1998-07-01Type 1 - New Molecular Entity · 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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