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FDA ANDA · ANDA070070

METHYLDOPA

Sponsor: ACCORD HLTHCARE

APPLICATION
ANDA070070
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-15
LATEST ACTION
2011-09-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METHYLDOPADiscontinued
METHYLDOPA 125MG · TABLET · ORAL

Approval history

2011-09-21Labeling · Supplement 24AP
1999-09-10Labeling · Supplement 23AP
1998-06-11Labeling · Supplement 22AP
1997-02-18Labeling · Supplement 21AP
1993-04-30Labeling · Supplement 20AP
1991-03-27Manufacturing (CMC) · Supplement 17AP
1991-03-27Manufacturing (CMC) · Supplement 18AP
1991-03-27Manufacturing (CMC) · Supplement 16AP
1991-03-20Labeling · Supplement 19AP
1990-12-12Labeling · Supplement 15AP
1990-03-28Manufacturing (CMC) · Supplement 13AP
1988-09-07Labeling · Supplement 10AP
1988-08-02Labeling · Supplement 11AP
1987-10-13Manufacturing (CMC) · Supplement 9AP
1987-10-13Manufacturing (CMC) · Supplement 8AP
1987-01-09Manufacturing (CMC) · Supplement 3AP
1987-01-09Manufacturing (CMC) · Supplement 4AP
1987-01-09Manufacturing (CMC) · Supplement 2AP
1985-10-15OriginalAP
VIEW ON DRUGS@FDA ↗

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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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