APPLICATION
ANDA075287
TYPE
ANDA
ORIGINAL APPROVAL
2000-09-18
LATEST ACTION
2002-03-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PEMOLINEDiscontinued
PEMOLINE 37.5MG · TABLET · ORAL
PEMOLINEDiscontinued
PEMOLINE 75MG · TABLET · ORAL
PEMOLINEDiscontinued
PEMOLINE 18.75MG · TABLET · ORAL
Approval history
2002-03-27Manufacturing (CMC) · Supplement 3AP
2001-06-13Labeling · Supplement 2AP
2001-06-13Manufacturing (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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