APPLICATION
ANDA040420
TYPE
ANDA
ORIGINAL APPROVAL
2002-04-19
LATEST ACTION
2010-02-02
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
PHENYTOINDiscontinued
PHENYTOIN 125MG/5ML · SUSPENSION · ORAL
Approval history
2010-02-02Labeling · Supplement 9AP
2005-04-20Labeling · Supplement 5AP
2003-12-09Labeling · Supplement 4AP
2002-11-06Manufacturing (CMC) · Supplement 3AP
2002-11-06Labeling · Supplement 2AP
2002-09-26Manufacturing (CMC) · Supplement 1AP
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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