APPLICATION
ANDA084307
TYPE
ANDA
ORIGINAL APPROVAL
1975-07-16
LATEST ACTION
2021-02-16
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PHENYTOIN SODIUM · ReferencePrescription
PHENYTOIN SODIUM 50MG/ML · INJECTABLE · INJECTION
Approval history
2021-02-16Labeling · Supplement 62 · standardAP
2020-09-28Labeling · Supplement 57 · standardAP
2020-09-28Labeling · Supplement 49 · standardAP
2020-09-28Labeling · Supplement 51 · standardAP
2020-09-28Labeling · Supplement 56 · standardAP
2020-09-28Labeling · Supplement 48 · standardAP
2020-09-28Labeling · Supplement 54 · standardAP
2020-09-28Labeling · Supplement 60 · standardAP
2014-01-27Labeling · Supplement 47 · standardAP
2014-01-27Labeling · Supplement 46AP
1998-12-11Labeling · Supplement 38AP
1998-08-19Labeling · Supplement 37AP
1998-02-09Manufacturing (CMC) · Supplement 36AP
1997-06-10Manufacturing (CMC) · Supplement 33AP
1997-05-27Manufacturing (CMC) · Supplement 34AP
1997-05-27Manufacturing (CMC) · Supplement 35AP
1995-11-27Labeling · Supplement 32AP
1993-11-18Manufacturing (CMC) · Supplement 31AP
1991-07-31Manufacturing (CMC) · Supplement 29AP
1990-12-28Labeling · Supplement 28AP
1990-05-18Manufacturing (CMC) · Supplement 27AP
1989-07-24Manufacturing (CMC) · Supplement 26AP
1988-08-10Labeling · Supplement 24AP
1987-10-02Manufacturing (CMC) · Supplement 18AP
1987-10-02Manufacturing (CMC) · Supplement 20AP
1987-10-02Manufacturing (CMC) · Supplement 19AP
1985-11-18Manufacturing (CMC) · Supplement 22AP
1985-04-18Manufacturing (CMC) · Supplement 17AP
1984-05-01Manufacturing (CMC) · Supplement 15AP
1983-02-14Manufacturing (CMC) · Supplement 13AP
1975-07-16OriginalAP
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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