APPLICATION
ANDA070698
TYPE
ANDA
ORIGINAL APPROVAL
1987-06-15
LATEST ACTION
1999-03-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
METHYLDOPATE HYDROCHLORIDEDiscontinued
METHYLDOPATE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
Approval history
1999-03-12Manufacturing (CMC) · Supplement 21AP
1999-03-12Manufacturing (CMC) · Supplement 18AP
1999-03-12Manufacturing (CMC) · Supplement 19AP
1998-08-14Labeling · Supplement 20AP
1997-01-07Manufacturing (CMC) · Supplement 16AP
1996-10-11Labeling · Supplement 15AP
1995-05-10Manufacturing (CMC) · Supplement 14AP
1994-11-03Labeling · Supplement 13AP
1993-12-22Manufacturing (CMC) · Supplement 12AP
1993-03-17Labeling · Supplement 10AP
1992-10-30Manufacturing (CMC) · Supplement 11AP
1992-04-27Manufacturing (CMC) · Supplement 9AP
1991-09-09Labeling · Supplement 7AP
1988-08-17Manufacturing (CMC) · Supplement 4AP
1988-08-17Manufacturing (CMC) · Supplement 5AP
1988-08-17Manufacturing (CMC) · Supplement 3AP
1988-07-15Labeling · Supplement 6AP
1987-11-06Labeling · Supplement 1AP
1987-06-15OriginalAP
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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