APPLICATION
NDA015103
TYPE
NDA
ORIGINAL APPROVAL
1964-05-08
LATEST ACTION
1988-08-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
REGROTONDiscontinued
CHLORTHALIDONE 50MG, RESERPINE 0.25MG · TABLET · ORAL
DEMI-REGROTONDiscontinued
CHLORTHALIDONE 25MG, RESERPINE 0.125MG · TABLET · ORAL
Approval history
1988-08-26Labeling · Supplement 38 · standardAP
1987-09-15Labeling · Supplement 37 · standardAP
1986-09-04Labeling · Supplement 36 · standardAP
1985-01-08Manufacturing (CMC) · Supplement 35 · standardAP
1983-07-18Labeling · Supplement 34 · standardAP
1983-06-03Manufacturing (CMC) · Supplement 33 · standardAP
1977-11-21Manufacturing (CMC) · Supplement 32 · standardAP
1977-09-07Manufacturing (CMC) · Supplement 31 · standardAP
1977-03-01Manufacturing (CMC) · Supplement 29 · standardAP
1976-11-12Manufacturing (CMC) · Supplement 28 · standardAP
1976-09-08Manufacturing (CMC) · Supplement 26 · standardAP
1976-05-03Manufacturing (CMC) · Supplement 27 · standardAP
1975-09-08Manufacturing (CMC) · Supplement 25 · standardAP
1975-07-17Manufacturing (CMC) · Supplement 23 · standardAP
1975-07-17Manufacturing (CMC) · Supplement 24 · standardAP
1975-07-17Manufacturing (CMC) · Supplement 22 · standardAP
1964-05-08Type 4 - New Combination · 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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