← FDA DRUG APPROVALS

FDA BLA · BLA020032

SURVANTA

beractant

Sponsor: ABBVIE

APPLICATION
BLA020032
TYPE
BLA
ORIGINAL APPROVAL
1991-07-01
LATEST ACTION
2022-07-15
ROUTE
ENDOTRACHEAL, INTRATRACHEAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

SURVANTAPrescription
BERACTANT 25MG/ML · SUSPENSION · INTRATRACHEAL

Approval history

2022-07-15Labeling · Supplement 47 · standard — Letter ↗AP
2020-10-26Labeling · Supplement 46 · standard — Label ↗AP
2019-12-16Labeling · Supplement 45 · standard — Label ↗AP
2016-02-25Manufacturing (CMC) · Supplement 43 · standardAP
2014-12-03Manufacturing (CMC) · Supplement 44 · standardAP
2013-06-12Manufacturing (CMC) · Supplement 42 · standardAP
2013-04-10Manufacturing (CMC) · Supplement 41 · standardAP
2009-02-10Labeling · Supplement 35 · standard — Letter ↗AP
2009-01-12Labeling · Supplement 36 · standard — Letter ↗AP
2005-04-28Manufacturing (CMC) · Supplement 26 · standard — Letter ↗AP
2002-12-06Manufacturing (CMC) · Supplement 23 · standardAP
2002-04-30Manufacturing (CMC) · Supplement 20 · standardAP
2001-03-23Manufacturing (CMC) · Supplement 19 · standardAP
2000-12-12Manufacturing (CMC) · Supplement 15 · standardAP
2000-11-27Manufacturing (CMC) · Supplement 18 · standardAP
2000-08-25Manufacturing (CMC) · Supplement 17 · standardAP
2000-02-24Manufacturing (CMC) · Supplement 14 · standardAP
1999-10-20Manufacturing (CMC) · Supplement 11 · standardAP
1999-10-14Manufacturing (CMC) · Supplement 13 · standardAP
1999-06-16Manufacturing (CMC) · Supplement 12 · standardAP
1998-12-09Manufacturing (CMC) · Supplement 10 · standardAP
1996-04-04Manufacturing (CMC) · Supplement 9 · standardAP
1995-03-10Labeling · Supplement 4AP
1994-09-27Manufacturing (CMC) · Supplement 8 · standardAP
1994-09-06Manufacturing (CMC) · Supplement 7 · standardAP
1994-08-29Manufacturing (CMC) · Supplement 6 · standardAP
1994-07-28Manufacturing (CMC) · Supplement 5 · standardAP
1994-03-24Manufacturing (CMC) · Supplement 2 · standardAP
1992-09-09Manufacturing (CMC) · Supplement 3 · standardAP
1992-08-17Manufacturing (CMC) · Supplement 1 · standardAP
1991-07-01Type 1 - New Molecular Entity · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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