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FDA ANDA · ANDA084349

DILANTIN

extended phenytoin sodium

Sponsor: VIATRIS

APPLICATION
ANDA084349
TYPE
ANDA
ORIGINAL APPROVAL
1976-08-27
LATEST ACTION
2022-09-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

DILANTIN · ReferencePrescription
PHENYTOIN SODIUM 30MG EXTENDED · CAPSULE · ORAL
DILANTIN · ReferencePrescription
PHENYTOIN SODIUM 100MG EXTENDED · CAPSULE · ORAL

Approval history

2022-09-07Labeling · Supplement 88 · standard — Medication Guide ↗AP
2021-10-22Labeling · Supplement 87 · standard — Label ↗AP
2020-08-07Labeling · Supplement 86 · standard — Label ↗AP
2018-12-03Labeling · Supplement 85 · standard — Label ↗AP
2017-12-22Labeling · Supplement 84 · standard — Label ↗AP
2017-12-22Labeling · Supplement 82 · standard — Label ↗AP
2017-12-22Labeling · Supplement 81 · standard — Label ↗AP
2017-02-01Labeling · Supplement 78 · standardAP
2017-02-01Labeling · Supplement 80 · standard — Label ↗AP
2017-02-01Labeling · Supplement 79 · standardAP
2017-02-01Labeling · Supplement 77 · standardAP
2017-02-01Labeling · Supplement 75 · standardAP
2015-04-16Labeling · Supplement 74 · standard — Label ↗AP
2014-07-03Labeling · Supplement 73 · standard — Label ↗AP
2014-02-27Labeling · Supplement 72 · standard — Label ↗AP
2014-02-27Labeling · Supplement 62 — Label ↗AP
2013-12-26Labeling · Supplement 71 · standardAP
2013-08-06Labeling · Supplement 70 · standard — Label ↗AP
2012-11-27Labeling · Supplement 67 — Label ↗AP
2011-04-08REMS · Supplement 64 — Label ↗AP
2009-07-09Labeling · Supplement 56AP
2009-05-06Labeling · Supplement 60 — Label ↗AP
2007-08-08Manufacturing (CMC) · Supplement 45 — Review ↗AP
2007-08-08Labeling · Supplement 41AP
2003-12-09Labeling · Supplement 40AP
1998-03-25Manufacturing (CMC) · Supplement 37AP
1998-03-25Manufacturing (CMC) · Supplement 38AP
1997-04-03Manufacturing (CMC) · Supplement 34AP
1997-02-12Manufacturing (CMC) · Supplement 31AP
1997-02-11Manufacturing (CMC) · Supplement 33AP
1996-09-19Manufacturing (CMC) · Supplement 35AP
1993-11-15Manufacturing (CMC) · Supplement 30AP
1990-03-22Bioequivalence · Supplement 26AP
1988-08-25Manufacturing (CMC) · Supplement 23AP
1988-08-25Manufacturing (CMC) · Supplement 24AP
1986-10-15Manufacturing (CMC) · Supplement 19AP
1986-02-11Manufacturing (CMC) · Supplement 20AP
1984-06-14Manufacturing (CMC) · Supplement 13AP
1984-04-09Manufacturing (CMC) · Supplement 11AP
1984-04-09Manufacturing (CMC) · Supplement 9AP
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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