APPLICATION
ANDA071279
TYPE
ANDA
ORIGINAL APPROVAL
1987-12-02
LATEST ACTION
2001-09-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
METHYLDOPATE HYDROCHLORIDEDiscontinued
METHYLDOPATE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
Approval history
2001-09-05Manufacturing (CMC) · Supplement 11AP
1998-06-16Labeling · Supplement 10AP
1998-01-29Manufacturing (CMC) · Supplement 9AP
1996-09-13Labeling · Supplement 8AP
1996-02-28Manufacturing (CMC) · Supplement 7AP
1995-03-20Manufacturing (CMC) · Supplement 5AP
1994-06-20Labeling · Supplement 6AP
1992-03-16Labeling · Supplement 4AP
1990-07-07Labeling · Supplement 1AP
1987-12-02OriginalAP
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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