APPLICATION
NDA012164
TYPE
NDA
ORIGINAL APPROVAL
1959-12-07
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NATURETIN-5Discontinued
BENDROFLUMETHIAZIDE 5MG · TABLET · ORAL
NATURETIN-10Discontinued
BENDROFLUMETHIAZIDE 10MG · TABLET · ORAL
NATURETIN-2.5Discontinued
BENDROFLUMETHIAZIDE 2.5MG · TABLET · ORAL
Approval history
2009-03-13Labeling · Supplement 14AP
2009-03-13Labeling · Supplement 15AP
1997-09-02Manufacturing (CMC) · Supplement 28 · standardAP
1996-10-01Manufacturing (CMC) · Supplement 27 · standardAP
1993-03-11Manufacturing (CMC) · Supplement 25 · standardAP
1991-08-07Manufacturing (CMC) · Supplement 26 · standardAP
1989-06-16Labeling · Supplement 20AP
1982-07-12Labeling · Supplement 24AP
1982-06-04Manufacturing (CMC) · Supplement 23 · standardAP
1982-02-19Manufacturing (CMC) · Supplement 22 · standardAP
1981-12-15Manufacturing (CMC) · Supplement 21 · standardAP
1979-05-04Labeling · Supplement 19AP
1977-06-16Labeling · Supplement 18AP
1977-06-16Manufacturing (CMC) · Supplement 17 · standardAP
1976-12-29Labeling · Supplement 16AP
1959-12-07Type 3 - New Dosage Form · Original · 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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