APPLICATION
NDA017938
TYPE
NDA
ORIGINAL APPROVAL
1979-12-28
LATEST ACTION
2002-01-15
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
MOBANDiscontinued
MOLINDONE HYDROCHLORIDE 20MG/ML · CONCENTRATE · ORAL
Approval history
2002-01-15Manufacturing (CMC) · Supplement 23 · standardAP
1998-08-21Manufacturing (CMC) · Supplement 21 · standardAP
1996-04-25Manufacturing (CMC) · Supplement 19 · standardAP
1995-08-28Manufacturing (CMC) · Supplement 18 · standardAP
1995-08-28Manufacturing (CMC) · Supplement 16 · standardAP
1995-08-28Manufacturing (CMC) · Supplement 17 · standardAP
1984-06-21Manufacturing (CMC) · Supplement 9 · standardAP
1982-11-19Labeling · Supplement 7 · standardAP
1981-11-16Manufacturing (CMC) · Supplement 4 · standardAP
1981-03-24Labeling · Supplement 3 · standardAP
1981-01-05Labeling · Supplement 2 · standardAP
1979-12-28Type 3 - New Dosage Form · Original · standardAP
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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