APPLICATION
NDA011878
TYPE
NDA
ORIGINAL APPROVAL
1959-05-05
LATEST ACTION
1987-05-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SERPASIL-ESIDRIX #2Discontinued
HYDROCHLOROTHIAZIDE 50MG, RESERPINE 0.1MG · TABLET · ORAL
SERPASIL-ESIDRIX #1Discontinued
HYDROCHLOROTHIAZIDE 25MG, RESERPINE 0.1MG · TABLET · ORAL
Approval history
1987-05-22Labeling · Supplement 30AP
1985-10-02Labeling · Supplement 29AP
1985-04-18Labeling · Supplement 26AP
1983-07-14Labeling · Supplement 27AP
1977-05-16Labeling · Supplement 20AP
1959-05-05Type 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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