APPLICATION
NDA013402
TYPE
NDA
ORIGINAL APPROVAL
1962-12-20
LATEST ACTION
2004-12-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ALDORIL 15Discontinued
HYDROCHLOROTHIAZIDE 15MG, METHYLDOPA 250MG · TABLET · ORAL
ALDORIL D50Discontinued
HYDROCHLOROTHIAZIDE 50MG, METHYLDOPA 500MG · TABLET · ORAL
ALDORIL 25Discontinued
HYDROCHLOROTHIAZIDE 25MG, METHYLDOPA 250MG · TABLET · ORAL
ALDORIL D30Discontinued
HYDROCHLOROTHIAZIDE 30MG, METHYLDOPA 500MG · TABLET · ORAL
Approval history
2002-04-05Manufacturing (CMC) · Supplement 84 · standardAP
1999-07-23Labeling · Supplement 81 · standardAP
1998-07-02Manufacturing (CMC) · Supplement 82 · standardAP
1997-08-05Labeling · Supplement 80 · standardAP
1995-11-29Manufacturing (CMC) · Supplement 79 · standardAP
1994-12-16Labeling · Supplement 77 · standardAP
1994-09-26Manufacturing (CMC) · Supplement 78 · standardAP
1994-03-07Labeling · Supplement 76 · standardAP
1993-03-24Labeling · Supplement 75 · standardAP
1992-12-18Labeling · Supplement 72 · standardAP
1992-09-17Labeling · Supplement 74 · standardAP
1990-09-13Labeling · Supplement 73 · standardAP
1988-04-26Manufacturing (CMC) · Supplement 70 · standardAP
1988-04-21Labeling · Supplement 71 · standardAP
1987-08-26Labeling · Supplement 69 · standardAP
1987-05-08Labeling · Supplement 56 · standardAP
1986-06-02Labeling · Supplement 68 · standardAP
1985-10-24Labeling · Supplement 67 · standardAP
1985-01-17Manufacturing (CMC) · Supplement 66 · standardAP
1984-11-15Labeling · Supplement 65 · standardAP
1984-08-13Labeling · Supplement 64 · standardAP
1984-04-10Manufacturing (CMC) · Supplement 62 · standardAP
1984-04-03Labeling · Supplement 63 · standardAP
1984-01-23Manufacturing (CMC) · Supplement 61 · standardAP
1983-12-23Manufacturing (CMC) · Supplement 60 · standardAP
1983-03-01Manufacturing (CMC) · Supplement 59 · standardAP
1982-09-08Labeling · Supplement 57 · standardAP
1982-04-19Manufacturing (CMC) · Supplement 58 · standardAP
1981-10-14Labeling · Supplement 55 · standardAP
1981-08-28Manufacturing (CMC) · Supplement 42 · standardAP
1981-06-17Manufacturing (CMC) · Supplement 53 · standardAP
1981-05-11Labeling · Supplement 52 · standardAP
1981-04-09Manufacturing (CMC) · Supplement 51 · standardAP
1981-03-04Manufacturing (CMC) · Supplement 50 · standardAP
1981-01-23Manufacturing (CMC) · Supplement 49 · standardAP
1980-11-14Manufacturing (CMC) · Supplement 48 · standardAP
1980-01-11Labeling · Supplement 47 · standardAP
1980-01-03Manufacturing (CMC) · Supplement 46 · standardAP
1979-10-31Labeling · Supplement 44 · standardAP
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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