← FDA DRUG APPROVALS

FDA BLA · BLA020744

CUROSURF

poractant alfa

Sponsor: CHIESI USA INC

APPLICATION
BLA020744
TYPE
BLA
ORIGINAL APPROVAL
1999-11-18
LATEST ACTION
2021-05-17
ROUTE
ENDOTRACHEAL, INTRATRACHEAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

CUROSURFPrescription
PORACTANT ALFA 80MG/ML · SUSPENSION · INTRATRACHEAL

Approval history

2021-05-17Labeling · Supplement 43 · standard — Label ↗AP
2019-12-16Labeling · Supplement 40 · standard — Letter ↗AP
2016-11-03Manufacturing (CMC) · Supplement 32 · standardAP
2016-11-01Manufacturing (CMC) · Supplement 33 · standardAP
2015-05-04Manufacturing (CMC) · Supplement 30 · standardAP
2014-10-15Manufacturing (CMC) · Supplement 29 · standardAP
2014-10-10Labeling · Supplement 28 · standard — Letter ↗AP
2014-02-12Manufacturing (CMC) · Supplement 27 · standardAP
2013-04-15Manufacturing (CMC) · Supplement 26 · standardAP
2013-04-15Manufacturing (CMC) · Supplement 25 · standardAP
2008-09-26Labeling · Supplement 19 · standard — Letter ↗AP
2004-02-17Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP
2002-12-13Manufacturing (CMC) · Supplement 9 · standardAP
2002-11-21Manufacturing (CMC) · Supplement 3 · standardAP
2002-06-03Manufacturing (CMC) · Supplement 6 · standardAP
2002-04-17Manufacturing (CMC) · Supplement 8 · standardAP
2002-04-05Manufacturing (CMC) · Supplement 5 · standardAP
2002-03-01Efficacy · Supplement 4 · standard — Letter ↗AP
2001-06-19Manufacturing (CMC) · Supplement 1 · standardAP
1999-11-18Type 1 - New Molecular Entity · Original · standard — Label ↗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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