← FDA DRUG APPROVALS

FDA NDA · NDA010151

DILANTIN

Sponsor: PARKE DAVIS

APPLICATION
NDA010151
TYPE
NDA
ORIGINAL APPROVAL
1956-03-01
LATEST ACTION
2017-10-31
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DILANTINDiscontinued
PHENYTOIN SODIUM 50MG/ML · INJECTABLE · INJECTION

Approval history

2017-10-31Labeling · Supplement 47 · standard — Label ↗AP
2017-10-31Labeling · Supplement 48 · standard — Label ↗AP
2017-08-15Labeling · Supplement 46 · standard — Label ↗AP
2016-11-30Labeling · Supplement 44 · standard — Letter ↗AP
2016-11-30Labeling · Supplement 45 · standard — Letter ↗AP
2016-06-16Labeling · Supplement 42 · standard — Label ↗AP
2016-01-25Labeling · Supplement 41 · standard — Label ↗AP
2015-04-15Labeling · Supplement 40 · standard — Letter ↗AP
2014-04-03Labeling · Supplement 39 · standard — Label ↗AP
2014-01-24Labeling · Supplement 38 · standard — Letter ↗AP
2013-03-06Labeling · Supplement 37 · standard — Label ↗AP
2011-11-13Labeling · Supplement 36 · standard — Label ↗AP
2001-11-20Labeling · Supplement 34 · standard — Review ↗AP
2001-11-20Labeling · Supplement 32 · standard — Review ↗AP
2001-11-20Labeling · Supplement 30 — Letter ↗AP
2001-11-20Labeling · Supplement 22 — Review ↗AP
2001-11-20Labeling · Supplement 29 — Letter ↗AP
2001-11-20Labeling · Supplement 33 · standard — Letter ↗AP
1997-05-30Manufacturing (CMC) · Supplement 35 · standardAP
1995-11-22Labeling · Supplement 31 · standardAP
1986-09-30Manufacturing (CMC) · Supplement 28 · standardAP
1986-09-30Manufacturing (CMC) · Supplement 27 · standardAP
1986-05-20Manufacturing (CMC) · Supplement 26 · standardAP
1983-08-10Manufacturing (CMC) · Supplement 23 · standardAP
1983-06-02Manufacturing (CMC) · Supplement 21 · standardAP
1981-12-15Labeling · Supplement 19AP
1981-06-03Manufacturing (CMC) · Supplement 17 · standardAP
1979-01-08Manufacturing (CMC) · Supplement 16 · standardAP
1978-11-30Labeling · Supplement 15AP
1978-01-09Labeling · Supplement 11AP
1977-01-28Manufacturing (CMC) · Supplement 13 · standardAP
1975-12-05Labeling · Supplement 10AP
1956-03-01Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →