APPLICATION
ANDA070291
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-01
LATEST ACTION
1996-11-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
METHYLDOPATE HYDROCHLORIDEDiscontinued
METHYLDOPATE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
Approval history
1996-11-14Labeling · Supplement 10AP
1994-02-08Labeling · Supplement 9AP
1992-01-21Manufacturing (CMC) · Supplement 6AP
1992-01-21Manufacturing (CMC) · Supplement 5AP
1991-09-10Labeling · Supplement 8AP
1991-08-07Manufacturing (CMC) · Supplement 4AP
1991-03-01Labeling · Supplement 7AP
1988-06-15Labeling · Supplement 3AP
1986-11-03Manufacturing (CMC) · Supplement 2AP
1986-07-01OriginalAP
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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