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FDA ANDA · ANDA084427

PHENYTOIN INFATABS

phenytoin

Sponsor: PHARMACIA

APPLICATION
ANDA084427
TYPE
ANDA
ORIGINAL APPROVAL
1979-02-26
LATEST ACTION
2023-05-08
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription

Products

DILANTIN · ReferencePrescription
PHENYTOIN 50MG · TABLET, CHEWABLE · ORAL

Approval history

2023-05-08Labeling · Supplement 45 · standardAP
2021-10-22Labeling · Supplement 44 · standardAP
2018-12-03Labeling · Supplement 42 · standard — Label ↗AP
2017-12-22Labeling · Supplement 38 · standard — Label ↗AP
2017-12-22Labeling · Supplement 39 · standard — Label ↗AP
2017-12-22Labeling · Supplement 41 · standard — Label ↗AP
2017-02-01Labeling · Supplement 36 · standardAP
2017-02-01Labeling · Supplement 34 · standardAP
2017-02-01Labeling · Supplement 37 · standard — Label ↗AP
2017-02-01Labeling · Supplement 35 · standardAP
2017-02-01Labeling · Supplement 33 · standardAP
2015-04-16Labeling · Supplement 32 · standard — Label ↗AP
2014-07-01Labeling · Supplement 31 · standard — Label ↗AP
2014-02-27Labeling · Supplement 30 · standard — Label ↗AP
2014-02-27Labeling · Supplement 22 — Label ↗AP
2014-02-27Labeling · Supplement 25 — Label ↗AP
2014-02-27Labeling · Supplement 17 — Label ↗AP
2013-12-26Labeling · Supplement 29 · standardAP
2013-08-06Labeling · Supplement 28 · standard — Label ↗AP
2012-11-27Labeling · Supplement 26 — Label ↗AP
2011-04-08REMS · Supplement 23 — Label ↗AP
2009-05-06Labeling · Supplement 20 — Label ↗AP
2003-06-06Labeling · Supplement 16AP
1997-10-10Manufacturing (CMC) · Supplement 15AP
1997-06-23Manufacturing (CMC) · Supplement 14AP
1996-08-05Manufacturing (CMC) · Supplement 12AP
1995-12-11Labeling · Supplement 13AP
1995-04-06Labeling · Supplement 11AP
1991-11-12Manufacturing (CMC) · Supplement 8AP
1991-11-12Manufacturing (CMC) · Supplement 9AP
1990-05-02Manufacturing (CMC) · Supplement 7AP
1982-05-17Manufacturing (CMC) · Supplement 2AP
1981-06-22Manufacturing (CMC) · Supplement 1AP
1979-02-26Original — 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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