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FDA NDA · NDA020450

CEREBYX

fosphenytoin sodium

Sponsor: PARKE DAVIS

APPLICATION
NDA020450
TYPE
NDA
ORIGINAL APPROVAL
1996-08-05
LATEST ACTION
2022-04-28
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CEREBYX · ReferencePrescription
FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML · INJECTABLE · INJECTION

Approval history

2022-04-28Labeling · Supplement 46 · standard — Label ↗AP
2021-12-02Labeling · Supplement 45 · standard — Label ↗AP
2021-02-16Labeling · Supplement 42 · standard — Letter ↗AP
2020-01-28Labeling · Supplement 40 · standard — Letter ↗AP
2019-07-12Labeling · Supplement 39 · standard — Letter ↗AP
2017-10-31Labeling · Supplement 37 · standard — Label ↗AP
2017-10-31Labeling · Supplement 38 · standard — Label ↗AP
2017-03-10Labeling · Supplement 36 · standard — Letter ↗AP
2017-03-01Efficacy · Supplement 3 · standard — Label ↗AP
2016-11-04Labeling · Supplement 33 · standard — Label ↗AP
2016-06-16Labeling · Supplement 31 · standard — Label ↗AP
2016-06-01Manufacturing (CMC) · Supplement 30 · standardAP
2016-03-03Labeling · Supplement 29 · standard — Letter ↗AP
2015-06-04Labeling · Supplement 28 · standard — Letter ↗AP
2014-06-12Labeling · Supplement 25 · standard — Label ↗AP
2014-06-09Manufacturing (CMC) · Supplement 26 · standardAP
2014-01-03Labeling · Supplement 23 · standard — Label ↗AP
2013-10-22Labeling · Supplement 24 · standard — Letter ↗AP
2013-08-30Manufacturing (CMC) · Supplement 21 · standardAP
2013-03-06Labeling · Supplement 20 · standard — Letter ↗AP
2011-11-13Labeling · Supplement 16 · standard — Label ↗AP
2011-11-13Labeling · Supplement 8 · standard — Label ↗AP
2011-11-13Labeling · Supplement 19 · unknown — Letter ↗AP
2011-11-13Labeling · Supplement 9 · standard — Letter ↗AP
2002-01-02Labeling · Supplement 7 · standardAP
2001-08-13Labeling · Supplement 4 · standard — Review ↗AP
2001-08-13Labeling · Supplement 5 · standard — Label ↗AP
1998-11-20Manufacturing (CMC) · Supplement 2 · standardAP
1996-12-26Labeling · Supplement 1 · standard — Review ↗AP
1996-08-05Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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