APPLICATION
ANDA070544
TYPE
ANDA
ORIGINAL APPROVAL
1986-01-15
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLDOPA AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 50MG, METHYLDOPA 500MG · TABLET · ORAL
Approval history
2020-08-20Labeling · Supplement 27 · standardAP
2020-08-06Labeling · Supplement 26 · standardAP
1998-11-25Manufacturing (CMC) · Supplement 21AP
1998-11-25Manufacturing (CMC) · Supplement 20AP
1996-08-19Manufacturing (CMC) · Supplement 17AP
1996-04-02Labeling · Supplement 18AP
1994-01-24Manufacturing (CMC) · Supplement 16AP
1993-08-02Labeling · Supplement 15AP
1993-04-30Labeling · Supplement 14AP
1992-01-31Labeling · Supplement 13AP
1989-09-15Labeling · Supplement 12AP
1988-02-17Manufacturing (CMC) · Supplement 10AP
1988-01-29Manufacturing (CMC) · Supplement 6AP
1986-12-11Manufacturing (CMC) · Supplement 2AP
1986-12-04Manufacturing (CMC) · Supplement 5AP
1986-12-04Manufacturing (CMC) · Supplement 3AP
1986-01-15OriginalAP
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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