APPLICATION
ANDA075030
TYPE
ANDA
ORIGINAL APPROVAL
1999-01-29
LATEST ACTION
2000-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PEMOLINEDiscontinued
PEMOLINE 18.75MG · TABLET · ORAL
PEMOLINEDiscontinued
PEMOLINE 37.5MG · TABLET · ORAL
PEMOLINEDiscontinued
PEMOLINE 75MG · TABLET · ORAL
Approval history
2000-12-07Manufacturing (CMC) · Supplement 12AP
2000-12-07Manufacturing (CMC) · Supplement 13AP
2000-12-07Manufacturing (CMC) · Supplement 11AP
2000-02-22Labeling · Supplement 10AP
2000-02-22Manufacturing (CMC) · Supplement 8AP
2000-02-22Manufacturing (CMC) · Supplement 9AP
1999-08-13Labeling · Supplement 7AP
1999-06-11Manufacturing (CMC) · Supplement 5AP
1999-06-11Manufacturing (CMC) · Supplement 1AP
1999-06-11Manufacturing (CMC) · Supplement 6AP
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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