APPLICATION
NDA013401
TYPE
NDA
ORIGINAL APPROVAL
1962-12-20
LATEST ACTION
1997-08-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ALDOMET · ReferenceDiscontinued
METHYLDOPATE HYDROCHLORIDE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1997-08-05Labeling · Supplement 47 · priorityAP
1997-08-05Labeling · Supplement 46 · priorityAP
1995-11-29Manufacturing (CMC) · Supplement 45 · priorityAP
1994-12-16Labeling · Supplement 44 · priorityAP
1993-03-24Labeling · Supplement 43 · priorityAP
1990-09-13Labeling · Supplement 42 · priorityAP
1989-11-06Labeling · Supplement 41 · priorityAP
1989-11-06Labeling · Supplement 33 · priorityAP
1987-05-11Labeling · Supplement 40 · priorityAP
1985-08-27Manufacturing (CMC) · Supplement 37 · priorityAP
1985-02-22Labeling · Supplement 39 · priorityAP
1984-10-11Manufacturing (CMC) · Supplement 38 · priorityAP
1984-09-24Labeling · Supplement 36 · priorityAP
1984-03-01Labeling · Supplement 35 · priorityAP
1982-09-08Labeling · Supplement 34 · priorityAP
1981-11-03Manufacturing (CMC) · Supplement 30 · priorityAP
1981-10-14Labeling · Supplement 32 · priorityAP
1981-07-14Manufacturing (CMC) · Supplement 31 · priorityAP
1981-05-01Labeling · Supplement 29 · priorityAP
1981-03-25Manufacturing (CMC) · Supplement 28 · priorityAP
1981-03-25Manufacturing (CMC) · Supplement 27 · priorityAP
1981-01-23Manufacturing (CMC) · Supplement 26 · priorityAP
1979-07-30Labeling · Supplement 23 · priorityAP
1979-02-07Manufacturing (CMC) · Supplement 25 · priorityAP
1978-11-07Manufacturing (CMC) · Supplement 24 · priorityAP
1976-11-09Manufacturing (CMC) · Supplement 21 · priorityAP
1976-07-22Labeling · Supplement 20 · priorityAP
1976-01-06Labeling · Supplement 19 · priorityAP
1975-07-11Manufacturing (CMC) · Supplement 18 · priorityAP
1975-06-06Manufacturing (CMC) · Supplement 17 · priorityAP
1975-04-30REMS · Supplement 13 · priorityAP
1962-12-20Type 2 - New Active Ingredient · Original · 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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