APPLICATION
ANDA075555
TYPE
ANDA
ORIGINAL APPROVAL
2000-02-18
LATEST ACTION
2001-10-10
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued
Products
PEMOLINEDiscontinued
PEMOLINE 37.5MG · TABLET, CHEWABLE · ORAL
Approval history
2001-10-10Manufacturing (CMC) · Supplement 6AP
2001-10-10Manufacturing (CMC) · Supplement 4AP
2001-10-10Manufacturing (CMC) · Supplement 5AP
2000-12-07Manufacturing (CMC) · Supplement 2AP
2000-12-07Manufacturing (CMC) · Supplement 3AP
2000-12-07Manufacturing (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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