APPLICATION
NDA018389
TYPE
NDA
ORIGINAL APPROVAL
1981-08-28
LATEST ACTION
1997-08-05
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
ALDOMETDiscontinued
METHYLDOPA 250MG/5ML · SUSPENSION · ORAL
Approval history
1997-08-05Labeling · Supplement 12 · standardAP
1997-08-05Labeling · Supplement 13 · standardAP
1994-12-16Labeling · Supplement 11 · standardAP
1992-09-03Labeling · Supplement 10 · standardAP
1990-09-13Labeling · Supplement 9 · standardAP
1988-11-22Labeling · Supplement 8 · standardAP
1987-05-11Labeling · Supplement 7 · standardAP
1987-05-11Labeling · Supplement 1 · standardAP
1985-10-22Labeling · Supplement 6 · standardAP
1985-02-22Labeling · Supplement 5 · standardAP
1984-03-05Labeling · Supplement 4 · standardAP
1983-12-23Manufacturing (CMC) · Supplement 3 · standardAP
1982-09-08Labeling · Supplement 2 · standardAP
1981-08-28Type 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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