APPLICATION
NDA016016
TYPE
NDA
ORIGINAL APPROVAL
1968-03-20
LATEST ACTION
1999-08-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ALDOCLOR-250Discontinued
CHLOROTHIAZIDE 250MG, METHYLDOPA 250MG · TABLET · ORAL
ALDOCLOR-150Discontinued
CHLOROTHIAZIDE 150MG, METHYLDOPA 250MG · TABLET · ORAL
Approval history
1999-08-22Labeling · Supplement 70 · standardAP
1997-08-05Labeling · Supplement 69 · standardAP
1997-05-23Manufacturing (CMC) · Supplement 68 · standardAP
1994-12-16Labeling · Supplement 66 · standardAP
1994-09-26Manufacturing (CMC) · Supplement 67 · standardAP
1994-06-30Labeling · Supplement 65 · standardAP
1992-09-17Labeling · Supplement 64 · standardAP
1992-09-03Labeling · Supplement 61 · standardAP
1990-09-13Labeling · Supplement 63 · standardAP
1988-09-06Manufacturing (CMC) · Supplement 62 · standardAP
1988-08-15Manufacturing (CMC) · Supplement 58 · standardAP
1988-04-21Labeling · Supplement 60 · standardAP
1987-08-26Labeling · Supplement 59 · standardAP
1987-05-08Labeling · Supplement 51 · standardAP
1986-06-02Labeling · Supplement 57 · standardAP
1986-01-14Labeling · Supplement 56 · standardAP
1984-09-24Labeling · Supplement 55 · standardAP
1984-04-03Labeling · Supplement 54 · standardAP
1983-12-23Manufacturing (CMC) · Supplement 53 · standardAP
1982-04-21Labeling · Supplement 52 · standardAP
1981-09-23Labeling · Supplement 50 · standardAP
1981-06-17Manufacturing (CMC) · Supplement 49 · standardAP
1981-04-27Labeling · Supplement 48 · standardAP
1981-04-09Manufacturing (CMC) · Supplement 47 · standardAP
1981-04-09Manufacturing (CMC) · Supplement 43 · standardAP
1981-01-23Manufacturing (CMC) · Supplement 46 · standardAP
1981-01-13Labeling · Supplement 45 · standardAP
1980-11-14Manufacturing (CMC) · Supplement 44 · standardAP
1979-11-29Labeling · Supplement 42 · standardAP
1979-09-18Labeling · Supplement 40 · standardAP
1979-07-03Labeling · Supplement 41 · standardAP
1979-06-18Manufacturing (CMC) · Supplement 36 · standardAP
1979-06-18Manufacturing (CMC) · Supplement 35 · standardAP
1979-03-09Manufacturing (CMC) · Supplement 39 · standardAP
1978-11-07Manufacturing (CMC) · Supplement 38 · standardAP
1978-09-12Labeling · Supplement 34 · standardAP
1978-09-12Labeling · Supplement 32 · standardAP
1978-08-29Manufacturing (CMC) · Supplement 37 · standardAP
1978-02-15Manufacturing (CMC) · Supplement 33 · standardAP
1976-11-09Manufacturing (CMC) · Supplement 31 · 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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