APPLICATION
ANDA040342
TYPE
ANDA
ORIGINAL APPROVAL
2001-01-31
LATEST ACTION
2024-04-12
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
PHENYTOINDiscontinued
PHENYTOIN 125MG/5ML · SUSPENSION · ORAL
PHENYTOINDiscontinued
PHENYTOIN 125MG/5ML · SUSPENSION · ORAL
Approval history
2024-04-12Labeling · Supplement 23 · standardAP
2021-07-02Labeling · Supplement 22 · standardAP
2021-07-02Labeling · Supplement 20 · standardAP
2021-07-02Labeling · Supplement 12 · standardAP
2021-07-02Labeling · Supplement 15 · standardAP
2021-07-02Labeling · Supplement 11 · standardAP
2014-01-15Labeling · Supplement 9 · standardAP
2014-01-15Labeling · Supplement 8 · standardAP
2014-01-15Labeling · Supplement 6AP
2010-01-26Labeling · Supplement 5AP
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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