APPLICATION
ANDA089892
TYPE
ANDA
ORIGINAL APPROVAL
1992-09-25
LATEST ACTION
2004-03-10
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
PHENYTOINDiscontinued
PHENYTOIN 125MG/5ML · SUSPENSION · ORAL
Approval history
2004-03-10Labeling · Supplement 17AP
2001-11-13Manufacturing (CMC) · Supplement 12AP
2000-12-18Manufacturing (CMC) · Supplement 9AP
2000-12-18Manufacturing (CMC) · Supplement 8AP
2000-11-02Manufacturing (CMC) · Supplement 11AP
1998-02-09Manufacturing (CMC) · Supplement 6AP
1998-02-09Manufacturing (CMC) · Supplement 5AP
1996-08-07Manufacturing (CMC) · Supplement 4AP
1996-08-07Manufacturing (CMC) · Supplement 2AP
1996-08-07Manufacturing (CMC) · Supplement 3AP
1996-08-07Manufacturing (CMC) · Supplement 1AP
1992-09-25OriginalAP
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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