APPLICATION
NDA013400
TYPE
NDA
ORIGINAL APPROVAL
1962-12-20
LATEST ACTION
2004-09-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ALDOMET · ReferenceDiscontinued
METHYLDOPA 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ALDOMET · ReferenceDiscontinued
METHYLDOPA 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ALDOMET · ReferenceDiscontinued
METHYLDOPA 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1998-11-10Labeling · Supplement 85 · priorityAP
1997-08-05Labeling · Supplement 84 · priorityAP
1997-08-05Labeling · Supplement 81 · priorityAP
1997-07-07Manufacturing (CMC) · Supplement 82 · priorityAP
1997-07-07Manufacturing (CMC) · Supplement 83 · priorityAP
1995-11-30Manufacturing (CMC) · Supplement 80 · priorityAP
1994-12-16Labeling · Supplement 78 · priorityAP
1994-09-26Manufacturing (CMC) · Supplement 79 · priorityAP
1992-09-03Labeling · Supplement 77 · priorityAP
1990-09-13Labeling · Supplement 76 · priorityAP
1988-11-22Labeling · Supplement 75 · priorityAP
1988-04-26Manufacturing (CMC) · Supplement 74 · priorityAP
1987-05-11Labeling · Supplement 73 · priorityAP
1987-05-11Labeling · Supplement 61 · priorityAP
1985-10-22Labeling · Supplement 72 · priorityAP
1985-02-22Labeling · Supplement 71 · priorityAP
1985-01-17Manufacturing (CMC) · Supplement 70 · priorityAP
1984-07-13Labeling · Supplement 69 · priorityAP
1984-04-10Manufacturing (CMC) · Supplement 68 · priorityAP
1984-03-01Labeling · Supplement 67 · priorityAP
1983-12-23Manufacturing (CMC) · Supplement 66 · priorityAP
1983-03-01Manufacturing (CMC) · Supplement 65 · priorityAP
1982-09-08Labeling · Supplement 63 · priorityAP
1982-04-19Manufacturing (CMC) · Supplement 64 · priorityAP
1982-04-07Manufacturing (CMC) · Supplement 51 · priorityAP
1982-04-07Manufacturing (CMC) · Supplement 62 · priorityAP
1981-11-17Labeling · Supplement 56 · priorityAP
1981-10-14Labeling · Supplement 60 · priorityAP
1981-08-28Manufacturing (CMC) · Supplement 58 · priorityAP
1981-08-28Manufacturing (CMC) · Supplement 55 · priorityAP
1981-06-17Manufacturing (CMC) · Supplement 57 · priorityAP
1981-04-09Manufacturing (CMC) · Supplement 54 · priorityAP
1981-01-23Manufacturing (CMC) · Supplement 53 · priorityAP
1980-11-14Manufacturing (CMC) · Supplement 52 · priorityAP
1979-10-10Manufacturing (CMC) · Supplement 50 · priorityAP
1979-07-25Labeling · Supplement 48 · priorityAP
1979-07-25Labeling · Supplement 42 · priorityAP
1979-03-09Manufacturing (CMC) · Supplement 47 · priorityAP
1978-11-07Manufacturing (CMC) · Supplement 46 · priorityAP
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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