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FDA ANDA · ANDA075286

PEMOLINE

Sponsor: FOSUN PHARMA

APPLICATION
ANDA075286
TYPE
ANDA
ORIGINAL APPROVAL
1999-06-30
LATEST ACTION
2002-12-20
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

2002-12-20Manufacturing (CMC) · Supplement 3AP
2002-12-20Manufacturing (CMC) · Supplement 4AP
1999-12-27Labeling · Supplement 2AP
1999-12-27Manufacturing (CMC) · Supplement 1AP
1999-06-30Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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