APPLICATION
ANDA070537
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-02
LATEST ACTION
2024-07-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLDOPADiscontinued
METHYLDOPA 500MG · TABLET · ORAL
Approval history
2024-07-26Labeling · Supplement 20 · standardAP
1996-04-11Labeling · Supplement 19AP
1994-05-18Manufacturing (CMC) · Supplement 18AP
1993-03-29Labeling · Supplement 17AP
1992-01-23Labeling · Supplement 16AP
1990-01-17Bioequivalence · Supplement 14AP
1989-05-09Labeling · Supplement 10AP
1988-02-09Labeling · Supplement 9AP
1988-01-29Manufacturing (CMC) · Supplement 7AP
1988-01-29Manufacturing (CMC) · Supplement 8AP
1987-10-13Manufacturing (CMC) · Supplement 5AP
1987-10-13Manufacturing (CMC) · Supplement 6AP
1987-08-20Labeling · Supplement 3AP
1987-08-20Manufacturing (CMC) · Supplement 4AP
1987-07-31Manufacturing (CMC) · Supplement 1AP
1987-07-31Manufacturing (CMC) · Supplement 2AP
1987-01-02OriginalAP
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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